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FDA 510(k)

ACCO(R) FACE MASK

K-Number: K880613 · 1988-03-04

ApplicantAbsorbent Cotton Co., Inc.
Decision Date1988-03-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCO(R) FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Absorbent Cotton Co., Inc.. It received FDA 510(k) clearance on 1988-03-04 under 510(k) number K880613. 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 ACCO(R) FACE MASK?

ACCO(R) FACE MASK is a medical device that received FDA 510(k) clearance on 1988-03-04. The listed applicant is Absorbent Cotton Co., Inc.. The 510(k) number is K880613.

When did ACCO(R) FACE MASK receive FDA 510(k) clearance?

ACCO(R) FACE MASK received FDA 510(k) clearance on 1988-03-04, under 510(k) number K880613.

Who is the listed applicant for ACCO(R) FACE MASK?

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

What is the FDA product code for ACCO(R) FACE MASK?

The FDA product code for ACCO(R) FACE MASK is FXX.

Other records listing Absorbent Cotton Co., 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.

K883250STERI-CLENS WOUND CARE KITK875129STERI-CLENSK874741STERI-CLENS(TM) SURGICAL SCRUB SPONGEK873523PLAIN DRY GAUZEK854740PRIMADERMK850126OIL EMULSION NON-ADHERING DRESSING

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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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