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FDA 510(k)

GOLNIT Non-Absorbable PTFE Surgical Suture

K-Number: K163049 · 2017-06-21

ApplicantAntarma Dba Golnit Sutures
Decision Date2017-06-21
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOLNIT Non-Absorbable PTFE Surgical Suture is a medical device manufactured by Antarma Dba Golnit Sutures. It received FDA 510(k) clearance on 2017-06-21 under approval number K163049. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLNIT Non-Absorbable PTFE Surgical Suture?

GOLNIT Non-Absorbable PTFE Surgical Suture is a medical device that received FDA 510(k) clearance on 2017-06-21. It is manufactured by Antarma Dba Golnit Sutures. The 510(k) number is K163049.

When was GOLNIT Non-Absorbable PTFE Surgical Suture approved by the FDA?

GOLNIT Non-Absorbable PTFE Surgical Suture received FDA 510(k) clearance on 2017-06-21, under approval number K163049.

What company makes GOLNIT Non-Absorbable PTFE Surgical Suture?

GOLNIT Non-Absorbable PTFE Surgical Suture is manufactured by Antarma Dba Golnit Sutures.

What is the FDA product code for GOLNIT Non-Absorbable PTFE Surgical Suture?

The FDA product code for GOLNIT Non-Absorbable PTFE Surgical Suture is NBY.

Related Clinical Trials

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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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