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FDA 510(k)

LUKENS NYLON SURGICAL SUTURE

K-Number: K930943 · 1993-12-17

ApplicantLukens Medical Corp.
Decision Date1993-12-17
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUKENS NYLON SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Lukens Medical Corp.. It received FDA 510(k) clearance on 1993-12-17 under 510(k) number K930943. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUKENS NYLON SURGICAL SUTURE?

LUKENS NYLON SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is Lukens Medical Corp.. The 510(k) number is K930943.

When did LUKENS NYLON SURGICAL SUTURE receive FDA 510(k) clearance?

LUKENS NYLON SURGICAL SUTURE received FDA 510(k) clearance on 1993-12-17, under 510(k) number K930943.

Who is the listed applicant for LUKENS NYLON SURGICAL SUTURE?

The FDA 510(k) record lists Lukens Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUKENS NYLON SURGICAL SUTURE?

The FDA product code for LUKENS NYLON SURGICAL SUTURE is GAR.

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Other records listing Lukens Medical Corp. 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.

K965162LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.K930942LUKENS SILK SURGICAL SUTUREK930945BRAIDED POLYESTER SURGICAL SUTUREK930941LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLEK930944LUKENS SURGICAL GUT SUTUREK930940LUKENS STAINLESS STEEL SURGICAL SUTURE

View all 8 devices →

Related Devices (Code: GAR)

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.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.

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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