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FDA 510(k)

SPONGE SURGICAL GUAZE RADIOPAQUE

K-Number: K802504 · 1980-11-12

ApplicantBarnhardt Mfg. Co.
Decision Date1980-11-12
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

SPONGE SURGICAL GUAZE RADIOPAQUE is the device name listed in this FDA 510(k) record. The listed applicant is Barnhardt Mfg. Co.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802504. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPONGE SURGICAL GUAZE RADIOPAQUE?

SPONGE SURGICAL GUAZE RADIOPAQUE is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Barnhardt Mfg. Co.. The 510(k) number is K802504.

When did SPONGE SURGICAL GUAZE RADIOPAQUE receive FDA 510(k) clearance?

SPONGE SURGICAL GUAZE RADIOPAQUE received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802504.

Who is the listed applicant for SPONGE SURGICAL GUAZE RADIOPAQUE?

The FDA 510(k) record lists Barnhardt Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPONGE SURGICAL GUAZE RADIOPAQUE?

The FDA product code for SPONGE SURGICAL GUAZE RADIOPAQUE 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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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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