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FDA 510(k)

LU-TEX II

K-Number: K904535 · 1991-01-30

ApplicantLukens Medical Corp.
Decision Date1991-01-30
Product CodeGAS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LU-TEX II 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 1991-01-30 under 510(k) number K904535. 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 LU-TEX II?

LU-TEX II is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Lukens Medical Corp.. The 510(k) number is K904535.

When did LU-TEX II receive FDA 510(k) clearance?

LU-TEX II received FDA 510(k) clearance on 1991-01-30, under 510(k) number K904535.

Who is the listed applicant for LU-TEX II?

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 LU-TEX II?

The FDA product code for LU-TEX II is GAS.

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.K930943LUKENS NYLON SURGICAL SUTUREK930945BRAIDED POLYESTER SURGICAL SUTUREK930942LUKENS SILK SURGICAL SUTUREK930941LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLEK930944LUKENS SURGICAL GUT SUTURE

View all 8 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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