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FDA 510(k)

ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P

K-Number: K123115 · 2013-05-20

ApplicantAcme Filter Mask, Inc.
Decision Date2013-05-20
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P is the device name listed in this FDA 510(k) record. The listed applicant is Acme Filter Mask, Inc.. It received FDA 510(k) clearance on 2013-05-20 under 510(k) number K123115. 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 ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P?

ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P is a medical device that received FDA 510(k) clearance on 2013-05-20. The listed applicant is Acme Filter Mask, Inc.. The 510(k) number is K123115.

When did ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P receive FDA 510(k) clearance?

ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P received FDA 510(k) clearance on 2013-05-20, under 510(k) number K123115.

Who is the listed applicant for ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P?

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

What is the FDA product code for ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P?

The FDA product code for ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P is FXX.

Related Clinical Trials

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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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