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FDA 510(k)

COVER, SHOE OPERATING ROOM

K-Number: K882280 · 1988-06-23

ApplicantA Plus International, Inc.
Decision Date1988-06-23
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COVER, SHOE OPERATING ROOM is the device name listed in this FDA 510(k) record. The listed applicant is A Plus International, Inc.. It received FDA 510(k) clearance on 1988-06-23 under 510(k) number K882280. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVER, SHOE OPERATING ROOM?

COVER, SHOE OPERATING ROOM is a medical device that received FDA 510(k) clearance on 1988-06-23. The listed applicant is A Plus International, Inc.. The 510(k) number is K882280.

When did COVER, SHOE OPERATING ROOM receive FDA 510(k) clearance?

COVER, SHOE OPERATING ROOM received FDA 510(k) clearance on 1988-06-23, under 510(k) number K882280.

Who is the listed applicant for COVER, SHOE OPERATING ROOM?

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

What is the FDA product code for COVER, SHOE OPERATING ROOM?

The FDA product code for COVER, SHOE OPERATING ROOM is FXP.

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Other records listing A Plus International, 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.

K213001Procedure Mask, Surgical MaskK102861SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)K093169SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)K031353SOLUTION FACE MASKSK882283BOUFFANT CAPK882281GOWN, ISOLATION, SURGICAL (FYC)

View all 11 devices →

Related Devices (Code: FXP)

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.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952897NIOMED SHOE COVERSAmerasia Corp.

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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