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FDA 510(k)

MASK, SURGICAL, FACE, DISPOSABLE

K-Number: K770463 · 1977-03-23

ApplicantPrecept, Inc.
Decision Date1977-03-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MASK, SURGICAL, FACE, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Precept, Inc.. It received FDA 510(k) clearance on 1977-03-23 under 510(k) number K770463. 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 MASK, SURGICAL, FACE, DISPOSABLE?

MASK, SURGICAL, FACE, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1977-03-23. The listed applicant is Precept, Inc.. The 510(k) number is K770463.

When did MASK, SURGICAL, FACE, DISPOSABLE receive FDA 510(k) clearance?

MASK, SURGICAL, FACE, DISPOSABLE received FDA 510(k) clearance on 1977-03-23, under 510(k) number K770463.

Who is the listed applicant for MASK, SURGICAL, FACE, DISPOSABLE?

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

What is the FDA product code for MASK, SURGICAL, FACE, DISPOSABLE?

The FDA product code for MASK, SURGICAL, FACE, DISPOSABLE 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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Other records listing Precept, 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.

K771409DISP. SURGICAL FACE MASKK770391COVER, ARMBOARD, DISPOSABLEK770021MASK, FACE, SURGICALK760360SHIRT, MITTEN CUFF INFANT

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

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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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