FDA 510(k)

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

Numéro K : K182828 · 2019-04-15

DemandeurSurgical Instrument Service and Savings, Inc.

Date de décision2019-04-15

Code produitNLM

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K182828. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K182828.

When did Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer received FDA 510(k) clearance on 2019-04-15, under 510(k) number K182828.

Who is the listed applicant for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

The FDA product code for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is NLM.

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Source officielle

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