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FDA 510(k)

INTESTINAL SPONGES

K-Number: K882710 · 1988-08-03

ApplicantBioseal
Decision Date1988-08-03
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

INTESTINAL SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Bioseal. It received FDA 510(k) clearance on 1988-08-03 under 510(k) number K882710. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTESTINAL SPONGES?

INTESTINAL SPONGES is a medical device that received FDA 510(k) clearance on 1988-08-03. The listed applicant is Bioseal. The 510(k) number is K882710.

When did INTESTINAL SPONGES receive FDA 510(k) clearance?

INTESTINAL SPONGES received FDA 510(k) clearance on 1988-08-03, under 510(k) number K882710.

Who is the listed applicant for INTESTINAL SPONGES?

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

What is the FDA product code for INTESTINAL SPONGES?

The FDA product code for INTESTINAL SPONGES is EFQ.

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Other records listing Bioseal 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.

K893814SURGICAL INSTRUMENT KIT, DISPOSABLEK882695RUBBER BAND, STERILEK882696DERMICEL, MONTGOMERY STRAPK882694FIXATION DEVICE, TRACH TUBEK882711GAUZE SPONGE 12PLYK882708GAUZE SPONGE, X-RAY DETECTABLE

View all 10 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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