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FDA 510(k)

PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL

K-Number: K974068 · 1997-12-22

ApplicantTecnol Medical Products, Inc.
Decision Date1997-12-22
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol Medical Products, Inc.. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K974068. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL?

PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Tecnol Medical Products, Inc.. The 510(k) number is K974068.

When did PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL receive FDA 510(k) clearance?

PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL received FDA 510(k) clearance on 1997-12-22, under 510(k) number K974068.

Who is the listed applicant for PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL?

The FDA 510(k) record lists Tecnol Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL?

The FDA product code for PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL is MSH.

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Other records listing Tecnol Medical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970448PCM 2000; ISOLAIR APR MODEL 2735K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)K963556SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)K963557SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030

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Related Devices (Code: MSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallOwens & Minor (O&M) Halyard, Inc.K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M HealthcareK160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M CompanyK102923BARRIER N95 PARTICULATE RESPIRATORMolnlycke Health Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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