The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Otsc Proctology.
| Device ID | K150067 |
| 510k Number | K150067 |
| Device Name: | OTSC Proctology |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 Tuebingen, DE 72074 |
| Contact | Marc O Schurr |
| Correspondent | Martina Krautwald novineon CRO &Consulting Ltd Dorfackerstrasse 26 Tuebingen, DE 72074 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-13 |
| Decision Date | 2015-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260206310266 | K150067 | 000 |