FDA 510(k)

N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695

K-Number: K092824 · 2009-10-21

Decision Date2009-10-21

Product CodeMSH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Protech, Inc.. It received FDA 510(k) clearance on 2009-10-21 under 510(k) number K092824. 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 N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695?

N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 is a medical device that received FDA 510(k) clearance on 2009-10-21. The listed applicant is Alpha Protech, Inc.. The 510(k) number is K092824.

When did N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 receive FDA 510(k) clearance?

N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 received FDA 510(k) clearance on 2009-10-21, under 510(k) number K092824.

Who is the listed applicant for N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695?

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

What is the FDA product code for N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695?

The FDA product code for N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 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 Alpha Protech, Inc. as applicant

K890128FACELOCK FILTER MASK

Related Devices (Code: MSH)

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 Healthcare K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M Company K102923BARRIER 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.