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FDA 510(k)

GAUZE CONVERSION CLASS I-NON-STERILE

K-Number: K832214 · 1983-07-26

ApplicantWinn Hirsch & Assoc.
Decision Date1983-07-26
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE CONVERSION CLASS I-NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Winn Hirsch & Assoc.. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K832214. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE CONVERSION CLASS I-NON-STERILE?

GAUZE CONVERSION CLASS I-NON-STERILE is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Winn Hirsch & Assoc.. The 510(k) number is K832214.

When did GAUZE CONVERSION CLASS I-NON-STERILE receive FDA 510(k) clearance?

GAUZE CONVERSION CLASS I-NON-STERILE received FDA 510(k) clearance on 1983-07-26, under 510(k) number K832214.

Who is the listed applicant for GAUZE CONVERSION CLASS I-NON-STERILE?

The FDA 510(k) record lists Winn Hirsch & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAUZE CONVERSION CLASS I-NON-STERILE?

The FDA product code for GAUZE CONVERSION CLASS I-NON-STERILE is EFQ.

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Other records listing Winn Hirsch & Assoc. 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.

K880309TYPE 316L STAINLESS STEEL WIREK864375TYPE 316L COTTER WIREK832213GAUZE CONVERSION CLASS II STERILEK830511ZANLEX, ZAN-TEX & ZANDEXK812390NEUROSPONGE PADDIEK812391NEUROSPONGES

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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