The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Provicol Qm Plus.
| Device ID | K161630 |
| 510k Number | K161630 |
| Device Name: | Provicol QM Plus |
| Classification | Zinc Oxide Eugenol |
| Applicant | VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven, DE 27472 |
| Contact | Th. Plaumann |
| Correspondent | T. Gerkensmeier VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven, DE 27472 |
| Product Code | EMB |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2016-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22110981 | K161630 | 000 |