SUPOLENE
Suture, Nonabsorbable, Synthetic, Polyethylene
RESORBA MEDICAL GMBH
The following data is part of a premarket notification filed by Resorba Medical Gmbh with the FDA for Supolene.
Pre-market Notification Details
| Device ID | K141072 |
| 510k Number | K141072 |
| Device Name: | SUPOLENE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | RESORBA MEDICAL GMBH AM FLACHMOOOR 16 Nuremberg, DE 90475 |
| Contact | Karl-josef Beck |
| Correspondent | Karl-josef Beck RESORBA MEDICAL GMBH AM FLACHMOOOR 16 Nuremberg, DE 90475 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-25 |
| Decision Date | 2014-06-23 |
Trademark Results [SUPOLENE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPOLENE 79197727 5184140 Live/Registered |
Resorba Medical GmbH 2016-06-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.