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FDA 510(k)

DEMETECH NYLON NONABSORBABLE SUTURE

K-Number: K023028 · 2003-06-18

ApplicantDemetech Corp.
Decision Date2003-06-18
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEMETECH NYLON NONABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Demetech Corp.. It received FDA 510(k) clearance on 2003-06-18 under 510(k) number K023028. 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 DEMETECH NYLON NONABSORBABLE SUTURE?

DEMETECH NYLON NONABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2003-06-18. The listed applicant is Demetech Corp.. The 510(k) number is K023028.

When did DEMETECH NYLON NONABSORBABLE SUTURE receive FDA 510(k) clearance?

DEMETECH NYLON NONABSORBABLE SUTURE received FDA 510(k) clearance on 2003-06-18, under 510(k) number K023028.

Who is the listed applicant for DEMETECH NYLON NONABSORBABLE SUTURE?

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

What is the FDA product code for DEMETECH NYLON NONABSORBABLE SUTURE?

The FDA product code for DEMETECH NYLON NONABSORBABLE SUTURE is GAR.

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Other records listing Demetech 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.

K130083DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTUREK082097DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTUREK072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTK043330POLYPROPILENE SURGICAL SUTURESK043539DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLESK023030DEMETECH POLYESTER NONABSORBABLE 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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