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FDA 510(k)

RAND SURGICAL SPONGE

K-Number: K971178 · 1997-06-27

ApplicantTrans Aire
Decision Date1997-06-27
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

RAND SURGICAL SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Trans Aire. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971178. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAND SURGICAL SPONGE?

RAND SURGICAL SPONGE is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Trans Aire. The 510(k) number is K971178.

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

RAND SURGICAL SPONGE received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971178.

Who is the listed applicant for RAND SURGICAL SPONGE?

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

What is the FDA product code for RAND SURGICAL SPONGE?

The FDA product code for RAND SURGICAL SPONGE is EFQ.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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