FDA 510(k) Application Details - K192953

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K192953
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	APTOS, LLC. 20/4 V. Orbeliani Street Tbilisi 0105 GE Other 510(k) Applications for this Company
Contact	Nikolai Pirtskhalaichvili Other 510(k) Applications for this Contact
Regulation Number	878.5010   More FDA Info for this Regulation Number
Classification Product Code	GAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2019
Decision Date	08/27/2020
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