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FDA 510(k)

TOMAC STERILE DISP. LAP SPONGE

K-Number: K812554 · 1981-09-24

ApplicantAmerican Convertors Div., American Pharmaseal
Decision Date1981-09-24
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOMAC STERILE DISP. LAP SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is American Convertors Div., American Pharmaseal. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812554. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMAC STERILE DISP. LAP SPONGE?

TOMAC STERILE DISP. LAP SPONGE is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is American Convertors Div., American Pharmaseal. The 510(k) number is K812554.

When did TOMAC STERILE DISP. LAP SPONGE receive FDA 510(k) clearance?

TOMAC STERILE DISP. LAP SPONGE received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812554.

Who is the listed applicant for TOMAC STERILE DISP. LAP SPONGE?

The FDA 510(k) record lists American Convertors Div., American Pharmaseal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOMAC STERILE DISP. LAP SPONGE?

The FDA product code for TOMAC STERILE DISP. LAP SPONGE is GDY.

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Other records listing American Convertors Div., American Pharmaseal 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.

K840957ANTIMICROBIAL INCISE DRAPEK832137CONVERTORS FLASH STERILIZING TRAYK830786DISIMETRIC RELEASE OF INSTRANETICS RADK820994ABSORB FURN SHEETK813419COMFORT CUSHION DRY BURN PAD IIIK813296CONVERTORS STERILE DISP. LAP SPONGE II

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Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives Corp.

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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