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FDA 510(k)

POLYESTER

K-Number: K994000 · 2000-02-04

ApplicantTrading Consultants and Distributors Intl., Inc.
Decision Date2000-02-04
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLYESTER is the device name listed in this FDA 510(k) record. The listed applicant is Trading Consultants and Distributors Intl., Inc.. It received FDA 510(k) clearance on 2000-02-04 under 510(k) number K994000. 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 POLYESTER?

POLYESTER is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Trading Consultants and Distributors Intl., Inc.. The 510(k) number is K994000.

When did POLYESTER receive FDA 510(k) clearance?

POLYESTER received FDA 510(k) clearance on 2000-02-04, under 510(k) number K994000.

Who is the listed applicant for POLYESTER?

The FDA 510(k) record lists Trading Consultants and Distributors Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYESTER?

The FDA product code for POLYESTER is GAT.

Related Clinical Trials

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.

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Other records listing Trading Consultants and Distributors Intl., Inc. 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.

K994001POLYGLYCOLIC ACIDK993997POLYPROPYLENEK994002PLAIN/CHROMIC CATGUTK993998NYLONK993999SILK

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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