The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Voco Retraction Paste.
| Device ID | K213149 |
| 510k Number | K213149 |
| Device Name: | VOCO Retraction Paste |
| Classification | Cord, Retraction |
| 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 | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2021-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22110141 | K213149 | 000 |
| E22110130 | K213149 | 000 |
| E22110121 | K213149 | 000 |