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FDA 510(k)

GAUZE SPONGE

K-Number: K936095 · 1994-02-02

ApplicantDukal Corp.
Decision Date1994-02-02
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corp.. It received FDA 510(k) clearance on 1994-02-02 under 510(k) number K936095. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGE?

GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1994-02-02. The listed applicant is Dukal Corp.. The 510(k) number is K936095.

When did GAUZE SPONGE receive FDA 510(k) clearance?

GAUZE SPONGE received FDA 510(k) clearance on 1994-02-02, under 510(k) number K936095.

Who is the listed applicant for GAUZE SPONGE?

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

What is the FDA product code for GAUZE SPONGE?

The FDA product code for GAUZE SPONGE is EFQ.

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Other records listing Dukal Corp. 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.

K083320DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPEK070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUEK061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560K020726DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGEK984564ETHYL CHLORIDE DISPENSERK970457DUKAL ABD COMBINE PAD

View all 11 devices →

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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