The following data is part of a premarket notification filed by Aptos, Llc. with the FDA for Aptos Threads – Polypropylene Surgical Sutures.
| Device ID | K192953 |
| 510k Number | K192953 |
| Device Name: | APTOS Threads – Polypropylene Surgical Sutures |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | APTOS, LLC. 20/4 V. Orbeliani Street Tbilisi, GE 0105 |
| Contact | Nikolai Pirtskhalaichvili |
| Correspondent | Nikolai Pirtskhalaichvili APTOS, LLC. 20/4 V. Orbeliani Street Tbilisi, GE 0105 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-21 |
| Decision Date | 2020-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04860120240351 | K192953 | 000 |
| 04860120240344 | K192953 | 000 |