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FDA 510(k)

NU-GAUZE SPONGE

K-Number: K821150 · 1982-08-27

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1982-08-27
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

NU-GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1982-08-27 under 510(k) number K821150. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NU-GAUZE SPONGE?

NU-GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1982-08-27. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K821150.

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

NU-GAUZE SPONGE received FDA 510(k) clearance on 1982-08-27, under 510(k) number K821150.

Who is the listed applicant for NU-GAUZE SPONGE?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NU-GAUZE SPONGE?

The FDA product code for NU-GAUZE SPONGE is EFQ.

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Other records listing Johnson & Johnson Professionals, Inc. as applicant

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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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