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FDA 510(k)

POLYESTER X-RAY DETECTABLE STRUNG-SPONGE

K-Number: K830201 · 1983-02-23

ApplicantAmerican Medical Disposable, Inc.
Decision Date1983-02-23
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLYESTER X-RAY DETECTABLE STRUNG-SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Disposable, Inc.. It received FDA 510(k) clearance on 1983-02-23 under 510(k) number K830201. 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 POLYESTER X-RAY DETECTABLE STRUNG-SPONGE?

POLYESTER X-RAY DETECTABLE STRUNG-SPONGE is a medical device that received FDA 510(k) clearance on 1983-02-23. The listed applicant is American Medical Disposable, Inc.. The 510(k) number is K830201.

When did POLYESTER X-RAY DETECTABLE STRUNG-SPONGE receive FDA 510(k) clearance?

POLYESTER X-RAY DETECTABLE STRUNG-SPONGE received FDA 510(k) clearance on 1983-02-23, under 510(k) number K830201.

Who is the listed applicant for POLYESTER X-RAY DETECTABLE STRUNG-SPONGE?

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

What is the FDA product code for POLYESTER X-RAY DETECTABLE STRUNG-SPONGE?

The FDA product code for POLYESTER X-RAY DETECTABLE STRUNG-SPONGE is GDY.

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Other records listing American Medical Disposable, Inc. 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.

K833734NEUROLOGICAL SPONGE ON PLASTIC STICKK833735AN ODOR ABSORBENT BANDAGEK833730NON ADHERENT BANDAGE/SHEETK833731BREATHABLE OVERWRAY BANDAGE NON-ELASK833729ELASTIC BREATHABLE OVER-WRAP BANDAGEK833733NON - ADHERENT BANDAGE

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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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