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FDA 510(k)

TWO-PLY PAPER FACE FACE MASK

K-Number: K832281 · 1983-08-12

ApplicantAbco Dealers, Inc.
Decision Date1983-08-12
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TWO-PLY PAPER FACE FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832281. 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 TWO-PLY PAPER FACE FACE MASK?

TWO-PLY PAPER FACE FACE MASK is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K832281.

When did TWO-PLY PAPER FACE FACE MASK receive FDA 510(k) clearance?

TWO-PLY PAPER FACE FACE MASK received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832281.

Who is the listed applicant for TWO-PLY PAPER FACE FACE MASK?

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

What is the FDA product code for TWO-PLY PAPER FACE FACE MASK?

The FDA product code for TWO-PLY PAPER FACE FACE MASK is FXX.

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Other records listing Abco Dealers, Inc. as applicant

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Related Devices (Code: FXX)

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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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