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FDA 510(k)

DEMETECH POLYESTER NONABSORBABLE SUTURE

K-Number: K023030 · 2003-06-18

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

Device Summary

DEMETECH POLYESTER 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 K023030. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEMETECH POLYESTER NONABSORBABLE SUTURE?

DEMETECH POLYESTER 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 K023030.

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

DEMETECH POLYESTER NONABSORBABLE SUTURE received FDA 510(k) clearance on 2003-06-18, under 510(k) number K023030.

Who is the listed applicant for DEMETECH POLYESTER 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 POLYESTER NONABSORBABLE SUTURE?

The FDA product code for DEMETECH POLYESTER NONABSORBABLE SUTURE is GAT.

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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 NEEDLESK023028DEMETECH NYLON NONABSORBABLE SUTURE

View all 8 devices →

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, 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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