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FDA 510(k)

TENCEL X-RAY DETECTABLE SPONGES/LAP PADS

K-Number: K932846 · 1993-12-09

ApplicantCourtaulds Fibers, Inc.
Decision Date1993-12-09
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TENCEL X-RAY DETECTABLE SPONGES/LAP PADS is the device name listed in this FDA 510(k) record. The listed applicant is Courtaulds Fibers, Inc.. It received FDA 510(k) clearance on 1993-12-09 under 510(k) number K932846. 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 TENCEL X-RAY DETECTABLE SPONGES/LAP PADS?

TENCEL X-RAY DETECTABLE SPONGES/LAP PADS is a medical device that received FDA 510(k) clearance on 1993-12-09. The listed applicant is Courtaulds Fibers, Inc.. The 510(k) number is K932846.

When did TENCEL X-RAY DETECTABLE SPONGES/LAP PADS receive FDA 510(k) clearance?

TENCEL X-RAY DETECTABLE SPONGES/LAP PADS received FDA 510(k) clearance on 1993-12-09, under 510(k) number K932846.

Who is the listed applicant for TENCEL X-RAY DETECTABLE SPONGES/LAP PADS?

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

What is the FDA product code for TENCEL X-RAY DETECTABLE SPONGES/LAP PADS?

The FDA product code for TENCEL X-RAY DETECTABLE SPONGES/LAP PADS 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 Courtaulds Fibers, 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.

K972458LYOCELL WOUND DRESSING/SURGICAL SPONGEK921227TENCEL TOPICAL WOUND DRESSING/SURGICAL 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.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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