FDA 510(k) Application Details - K220980

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide

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510(K) Number K220980
Device Name Suture, Nonabsorbable, Synthetic, Polyamide
Applicant TAS Medical, Inc.
1100 Industrial Road
San Carlos, CA 94070 US
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Contact Michael Tozzi
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Regulation Number 878.5020

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Classification Product Code GAR
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Date Received 04/04/2022
Decision Date 07/05/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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