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FDA 510(k)

GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)

K-Number: K951911 · 1995-06-21

ApplicantCommercial Resources New Mexico, Ltd.
Decision Date1995-06-21
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) is the device name listed in this FDA 510(k) record. The listed applicant is Commercial Resources New Mexico, Ltd.. It received FDA 510(k) clearance on 1995-06-21 under 510(k) number K951911. 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 GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)?

GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) is a medical device that received FDA 510(k) clearance on 1995-06-21. The listed applicant is Commercial Resources New Mexico, Ltd.. The 510(k) number is K951911.

When did GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) receive FDA 510(k) clearance?

GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) received FDA 510(k) clearance on 1995-06-21, under 510(k) number K951911.

Who is the listed applicant for GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)?

The FDA 510(k) record lists Commercial Resources New Mexico, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)?

The FDA product code for GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) 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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