PERMATAPE
Suture, Nonabsorbable, Synthetic, Polyethylene
MEDOS INTERNATIONAL SARL
The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Permatape.
Pre-market Notification Details
| Device ID | K162247 |
| 510k Number | K162247 |
| Device Name: | PERMATAPE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38 Le Locle Neuchatel, CH 2400 |
| Contact | Tatyana Korsunsky |
| Correspondent | Tatyana Korsunsky DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 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 | 2016-08-10 |
| Decision Date | 2016-12-15 |
| Summary: | summary |
Trademark Results [PERMATAPE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERMATAPE 86916308 5266889 Live/Registered |
Depuy Synthes, Inc. 2016-02-23 |
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