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FDA 510(k)

MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95

K-Number: K020474 · 2002-07-23

ApplicantMakrite Industries, Inc.
Decision Date2002-07-23
Product CodeMSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 is the device name listed in this FDA 510(k) record. The listed applicant is Makrite Industries, Inc.. It received FDA 510(k) clearance on 2002-07-23 under 510(k) number K020474. 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 MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95?

MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 is a medical device that received FDA 510(k) clearance on 2002-07-23. The listed applicant is Makrite Industries, Inc.. The 510(k) number is K020474.

When did MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 receive FDA 510(k) clearance?

MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 received FDA 510(k) clearance on 2002-07-23, under 510(k) number K020474.

Who is the listed applicant for MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95?

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

What is the FDA product code for MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95?

The FDA product code for MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 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 Makrite Industries, 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.

K252650Disposable Medical Face MaskK240258Disposable Medical Face Mask (M643BE)K220550Disposable Surgical Face Mask (M663BE, M663BT)

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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