The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio Seal.
| Device ID | K062344 |
| 510k Number | K062344 |
| Device Name: | GRANDIO SEAL |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Michael Sues |
| Correspondent | Michael Sues VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-11 |
| Decision Date | 2006-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22110611 | K062344 | 000 |
| E22110601 | K062344 | 000 |