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FDA 510(k)

GAUZE DRESSING

K-Number: K935241 · 1994-01-25

ApplicantChak Tak (Shen Zhen) Enterprises, Ltd.
Decision Date1994-01-25
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Chak Tak (Shen Zhen) Enterprises, Ltd.. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K935241. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE DRESSING?

GAUZE DRESSING is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Chak Tak (Shen Zhen) Enterprises, Ltd.. The 510(k) number is K935241.

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

GAUZE DRESSING received FDA 510(k) clearance on 1994-01-25, under 510(k) number K935241.

Who is the listed applicant for GAUZE DRESSING?

The FDA 510(k) record lists Chak Tak (Shen Zhen) Enterprises, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAUZE DRESSING?

The FDA product code for GAUZE DRESSING is EFQ.

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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

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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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