The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Permaloop Suture, Permatape Suture.
| Device ID | K220219 |
| 510k Number | K220219 |
| Device Name: | PERMALOOP Suture, PERMATAPE Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH CH 2400 |
| Contact | Ashley Aromando (Goncalo) |
| Correspondent | Ashley Aromando (Goncalo) DePuy Synthes Mitek Sports Medicine 325 Paramount Drive Raynham, MA 02767 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-26 |
| Decision Date | 2022-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705032808 | K220219 | 000 |
| 10886705032747 | K220219 | 000 |
| 10886705032754 | K220219 | 000 |
| 10886705032761 | K220219 | 000 |
| 10886705032778 | K220219 | 000 |
| 10886705032785 | K220219 | 000 |
| 10886705032792 | K220219 | 000 |
| 10886705032815 | K220219 | 000 |
| 10886705031511 | K220219 | 000 |
| 10886705031528 | K220219 | 000 |
| 10886705031535 | K220219 | 000 |
| 10886705031542 | K220219 | 000 |
| 10886705031559 | K220219 | 000 |
| 10886705031566 | K220219 | 000 |
| 10886705032723 | K220219 | 000 |
| 10886705032730 | K220219 | 000 |