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FDA 510(k)

PROTEC X-RAY DETECTABLE GAUZE SPONGE

K-Number: K955322 · 1995-12-19

ApplicantDerivados DE Gasa, S.A. DE C.V.
Decision Date1995-12-19
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROTEC X-RAY DETECTABLE GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Derivados DE Gasa, S.A. DE C.V.. It received FDA 510(k) clearance on 1995-12-19 under 510(k) number K955322. 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 PROTEC X-RAY DETECTABLE GAUZE SPONGE?

PROTEC X-RAY DETECTABLE GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1995-12-19. The listed applicant is Derivados DE Gasa, S.A. DE C.V.. The 510(k) number is K955322.

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

PROTEC X-RAY DETECTABLE GAUZE SPONGE received FDA 510(k) clearance on 1995-12-19, under 510(k) number K955322.

Who is the listed applicant for PROTEC X-RAY DETECTABLE GAUZE SPONGE?

The FDA 510(k) record lists Derivados DE Gasa, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTEC X-RAY DETECTABLE GAUZE SPONGE?

The FDA product code for PROTEC X-RAY DETECTABLE GAUZE SPONGE is GDY.

Related Clinical Trials

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.

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Other records listing Derivados DE Gasa, S.A. DE C.V. 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.

K955321PROTEC GAUZE SPONGE

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.K953830KENSORBKentron Health Care, Inc.K953058ROUND STICK SPONGES, FLAT STICK SPONGESMedical Perspectives Corp.K953088TRIANGULAR SPONGESMedical 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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