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FDA 510(k)

DACRON R SURGICAL SUTURES

K-Number: K904263 · 1990-10-16

ApplicantSharppoint, Inc.
Decision Date1990-10-16
Product CodeGAS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DACRON R SURGICAL SUTURES is the device name listed in this FDA 510(k) record. The listed applicant is Sharppoint, Inc.. It received FDA 510(k) clearance on 1990-10-16 under 510(k) number K904263. 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 DACRON R SURGICAL SUTURES?

DACRON R SURGICAL SUTURES is a medical device that received FDA 510(k) clearance on 1990-10-16. The listed applicant is Sharppoint, Inc.. The 510(k) number is K904263.

When did DACRON R SURGICAL SUTURES receive FDA 510(k) clearance?

DACRON R SURGICAL SUTURES received FDA 510(k) clearance on 1990-10-16, under 510(k) number K904263.

Who is the listed applicant for DACRON R SURGICAL SUTURES?

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

What is the FDA product code for DACRON R SURGICAL SUTURES?

The FDA product code for DACRON R SURGICAL SUTURES is GAS.

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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

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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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