The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Final Varnish Lc.
| Device ID | K030844 |
| 510k Number | K030844 |
| Device Name: | FINAL VARNISH LC |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | VOCO GMBH 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps VOCO GMBH 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-17 |
| Decision Date | 2003-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22112411 | K030844 | 000 |