The following data is part of a premarket notification filed by Voco Gmbh with the FDA for V-print Splint.
| Device ID | K201091 |
| 510k Number | K201091 |
| Device Name: | V-Print Splint |
| Classification | Mouthguard, Prescription |
| Applicant | VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Contact | M. Th. Plaumann |
| Correspondent | T. Gerkensmeier VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-23 |
| Decision Date | 2020-11-06 |