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FDA 510(k)

GAUZE AND LAP SPONGES -STERILE & NON-STERILE

K-Number: K881395 · 1988-04-28

ApplicantA Plus International, Inc.
Decision Date1988-04-28
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE AND LAP SPONGES -STERILE & NON-STERILE 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 1988-04-28 under 510(k) number K881395. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE AND LAP SPONGES -STERILE & NON-STERILE?

GAUZE AND LAP SPONGES -STERILE & NON-STERILE is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is A Plus International, Inc.. The 510(k) number is K881395.

When did GAUZE AND LAP SPONGES -STERILE & NON-STERILE receive FDA 510(k) clearance?

GAUZE AND LAP SPONGES -STERILE & NON-STERILE received FDA 510(k) clearance on 1988-04-28, under 510(k) number K881395.

Who is the listed applicant for GAUZE AND LAP SPONGES -STERILE & NON-STERILE?

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 GAUZE AND LAP SPONGES -STERILE & NON-STERILE?

The FDA product code for GAUZE AND LAP SPONGES -STERILE & NON-STERILE is EFQ.

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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 MASKSK882284SURGEONS CAPK882283BOUFFANT CAP

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Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.

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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