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FDA 510(k)

FLUFF GAUZE SPONGE

K-Number: K945020 · 1994-12-23

ApplicantClinical Resources, Inc.
Decision Date1994-12-23
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

FLUFF GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Resources, Inc.. It received FDA 510(k) clearance on 1994-12-23 under 510(k) number K945020. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUFF GAUZE SPONGE?

FLUFF GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1994-12-23. The listed applicant is Clinical Resources, Inc.. The 510(k) number is K945020.

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

FLUFF GAUZE SPONGE received FDA 510(k) clearance on 1994-12-23, under 510(k) number K945020.

Who is the listed applicant for FLUFF GAUZE SPONGE?

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

What is the FDA product code for FLUFF GAUZE SPONGE?

The FDA product code for FLUFF GAUZE SPONGE is EFQ.

Related Clinical Trials

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.

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Other records listing Clinical Resources, Inc. 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.

K941470TRACHEOSTOMY CARE KITK944882IRRIGATION TRAYK944881SKIN SCRUB TRAYK944879GAUZE SPONGESK945021FLUFF GAUZE SPONGEK945019FLUFF GAUXZE ROLL

View all 14 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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