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FDA 510(k)

LAPAROTOMY SPONGES

K-Number: K905135 · 1991-03-06

ApplicantAmerican Healthcare Corp.
Decision Date1991-03-06
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAPAROTOMY SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is American Healthcare Corp.. It received FDA 510(k) clearance on 1991-03-06 under 510(k) number K905135. 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 LAPAROTOMY SPONGES?

LAPAROTOMY SPONGES is a medical device that received FDA 510(k) clearance on 1991-03-06. The listed applicant is American Healthcare Corp.. The 510(k) number is K905135.

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

LAPAROTOMY SPONGES received FDA 510(k) clearance on 1991-03-06, under 510(k) number K905135.

Who is the listed applicant for LAPAROTOMY SPONGES?

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

What is the FDA product code for LAPAROTOMY SPONGES?

The FDA product code for LAPAROTOMY SPONGES is GDY.

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Other records listing American Healthcare Corp. 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.

K924192I.V. START KIT (AHC-50-54954K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEK923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEK923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERK923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERK924193TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)

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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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