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FDA 510(k)

GAUZE & COTTON SPONGES

K-Number: K790389 · 1979-03-26

ApplicantMedtech Intl., Inc.
Decision Date1979-03-26
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAUZE & COTTON SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Medtech Intl., Inc.. It received FDA 510(k) clearance on 1979-03-26 under 510(k) number K790389. 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 & COTTON SPONGES?

GAUZE & COTTON SPONGES is a medical device that received FDA 510(k) clearance on 1979-03-26. The listed applicant is Medtech Intl., Inc.. The 510(k) number is K790389.

When did GAUZE & COTTON SPONGES receive FDA 510(k) clearance?

GAUZE & COTTON SPONGES received FDA 510(k) clearance on 1979-03-26, under 510(k) number K790389.

Who is the listed applicant for GAUZE & COTTON SPONGES?

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

What is the FDA product code for GAUZE & COTTON SPONGES?

The FDA product code for GAUZE & COTTON SPONGES is GDY.

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Other records listing Medtech Intl., Inc. as applicant

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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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