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FDA 510(k)

POLYVIOLENE(TM) SUTURE

K-Number: K904054 · 1990-10-03

ApplicantLook, Inc.
Decision Date1990-10-03
Product CodeGAS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLYVIOLENE(TM) SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Look, Inc.. It received FDA 510(k) clearance on 1990-10-03 under 510(k) number K904054. The device is classified under product code GAS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYVIOLENE(TM) SUTURE?

POLYVIOLENE(TM) SUTURE is a medical device that received FDA 510(k) clearance on 1990-10-03. The listed applicant is Look, Inc.. The 510(k) number is K904054.

When did POLYVIOLENE(TM) SUTURE receive FDA 510(k) clearance?

POLYVIOLENE(TM) SUTURE received FDA 510(k) clearance on 1990-10-03, under 510(k) number K904054.

Who is the listed applicant for POLYVIOLENE(TM) SUTURE?

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

What is the FDA product code for POLYVIOLENE(TM) SUTURE?

The FDA product code for POLYVIOLENE(TM) SUTURE is GAS.

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 Look, 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.

K943949POLYVIOLENE SURGICL SUTUREK933686LOOK INC. 316L STAINLESS STEEL SURGICAL SUTUREK926586REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURESK926168SILK SUTURES-REVISED LABELINGK926167POLYVIOLENE SUTURE-REVISED LABELINGK926587REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)

View all 25 devices →

Related Devices (Code: GAS)

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.

K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneLsi Solutions, Inc.K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi SolutionsK091018ARTHREX BIOWIREArthrex, Inc.K002261MR-IIISmith & Nephew, Inc.K953128SUTURE CORDPhoenix Biomedical Corp.K923161BRAIDED POLYESTER SUTURE MATERIALMitek Surgical Products, 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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