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FDA 510(k)

SURGICAL MASK (NON-STERILE)

K-Number: K955513 · 1996-04-22

ApplicantUnited Medical Ent., Inc.
Decision Date1996-04-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL MASK (NON-STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is United Medical Ent., Inc.. It received FDA 510(k) clearance on 1996-04-22 under 510(k) number K955513. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL MASK (NON-STERILE)?

SURGICAL MASK (NON-STERILE) is a medical device that received FDA 510(k) clearance on 1996-04-22. The listed applicant is United Medical Ent., Inc.. The 510(k) number is K955513.

When did SURGICAL MASK (NON-STERILE) receive FDA 510(k) clearance?

SURGICAL MASK (NON-STERILE) received FDA 510(k) clearance on 1996-04-22, under 510(k) number K955513.

Who is the listed applicant for SURGICAL MASK (NON-STERILE)?

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

What is the FDA product code for SURGICAL MASK (NON-STERILE)?

The FDA product code for SURGICAL MASK (NON-STERILE) is FXX.

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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Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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