The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Fit Test C&b.
| Device ID | K110050 |
| 510k Number | K110050 |
| Device Name: | FIT TEST C&B |
| Classification | Material, Impression |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Manfred T Plaumann |
| Correspondent | Manfred T Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-07 |
| Decision Date | 2011-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22120951 | K110050 | 000 |
| E22116251 | K110050 | 000 |