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FDA 510(k)

SPONGE, LAPAROTOMY, VARIOUS SIZE

K-Number: K940436 · 1994-07-26

ApplicantShawnee Products, Inc.
Decision Date1994-07-26
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPONGE, LAPAROTOMY, VARIOUS SIZE is the device name listed in this FDA 510(k) record. The listed applicant is Shawnee Products, Inc.. It received FDA 510(k) clearance on 1994-07-26 under 510(k) number K940436. 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 SPONGE, LAPAROTOMY, VARIOUS SIZE?

SPONGE, LAPAROTOMY, VARIOUS SIZE is a medical device that received FDA 510(k) clearance on 1994-07-26. The listed applicant is Shawnee Products, Inc.. The 510(k) number is K940436.

When did SPONGE, LAPAROTOMY, VARIOUS SIZE receive FDA 510(k) clearance?

SPONGE, LAPAROTOMY, VARIOUS SIZE received FDA 510(k) clearance on 1994-07-26, under 510(k) number K940436.

Who is the listed applicant for SPONGE, LAPAROTOMY, VARIOUS SIZE?

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

What is the FDA product code for SPONGE, LAPAROTOMY, VARIOUS SIZE?

The FDA product code for SPONGE, LAPAROTOMY, VARIOUS SIZE is GDY.

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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

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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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