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FDA 510(k)

MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS

K-Number: K062663 · 2006-10-11

ApplicantMoldex/Metric, Inc.
Decision Date2006-10-11
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Moldex/Metric, Inc.. It received FDA 510(k) clearance on 2006-10-11 under 510(k) number K062663. 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 MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS?

MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS is a medical device that received FDA 510(k) clearance on 2006-10-11. The listed applicant is Moldex/Metric, Inc.. The 510(k) number is K062663.

When did MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS receive FDA 510(k) clearance?

MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS received FDA 510(k) clearance on 2006-10-11, under 510(k) number K062663.

Who is the listed applicant for MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS?

The FDA 510(k) record lists Moldex/Metric, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS?

The FDA product code for MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS is MSH.

Related Clinical Trials

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.

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Other records listing Moldex/Metric, 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.

K102173MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712

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

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

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