APTOS Threads – Polypropylene Surgical Sutures

Suture, Nonabsorbable, Synthetic, Polypropylene

APTOS, LLC.

The following data is part of a premarket notification filed by Aptos, Llc. with the FDA for Aptos Threads – Polypropylene Surgical Sutures.

Pre-market Notification Details

Device IDK192953
510k NumberK192953
Device Name:APTOS Threads – Polypropylene Surgical Sutures
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant APTOS, LLC. 20/4 V. Orbeliani Street Tbilisi,  GE 0105
ContactNikolai Pirtskhalaichvili
CorrespondentNikolai Pirtskhalaichvili
APTOS, LLC. 20/4 V. Orbeliani Street Tbilisi,  GE 0105
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-21
Decision Date2020-08-27

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