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FDA 510(k)

GAUZE SPONGE, NON X-RAY DETECTABLE

K-Number: K963724 · 1996-11-29

ApplicantGrand Medical Products
Decision Date1996-11-29
Product CodeEFQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

GAUZE SPONGE, NON X-RAY DETECTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Grand Medical Products. It received FDA 510(k) clearance on 1996-11-29 under 510(k) number K963724. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the GAUZE SPONGE, NON X-RAY DETECTABLE?

GAUZE SPONGE, NON X-RAY DETECTABLE is a medical device that received FDA 510(k) clearance on 1996-11-29. The listed applicant is Grand Medical Products. The 510(k) number is K963724.

When did GAUZE SPONGE, NON X-RAY DETECTABLE receive FDA 510(k) clearance?

GAUZE SPONGE, NON X-RAY DETECTABLE received FDA 510(k) clearance on 1996-11-29, under 510(k) number K963724.

Who is the listed applicant for GAUZE SPONGE, NON X-RAY DETECTABLE?

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

What is the FDA product code for GAUZE SPONGE, NON X-RAY DETECTABLE?

The FDA product code for GAUZE SPONGE, NON X-RAY DETECTABLE is EFQ.

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Other records listing Grand Medical Products 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.

K963723LACERATION TRAYK963721SKIN SCRUB TRAYK963719CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAYK963720TRACHEOSTOMY KITK963714GRAND MEDICAL SUTURE REMOVAL KITK963722IV START KIT

View all 8 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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