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FDA 510(k)

TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE

K-Number: K921227 · 1992-05-29

ApplicantCourtaulds Fibers, Inc.
Decision Date1992-05-29
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE 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 1992-05-29 under 510(k) number K921227. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE?

TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE is a medical device that received FDA 510(k) clearance on 1992-05-29. The listed applicant is Courtaulds Fibers, Inc.. The 510(k) number is K921227.

When did TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE receive FDA 510(k) clearance?

TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE received FDA 510(k) clearance on 1992-05-29, under 510(k) number K921227.

Who is the listed applicant for TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE?

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 TOPICAL WOUND DRESSING/SURGICAL SPONGE?

The FDA product code for TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE is NAB.

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 SPONGEK932846TENCEL X-RAY DETECTABLE SPONGES/LAP PADS

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, Inc.

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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