The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Modification To:registrado X-tra.
| Device ID | K051535 |
| 510k Number | K051535 |
| Device Name: | MODIFICATION TO:REGISTRADO X-TRA |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-10 |
| Decision Date | 2005-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D989SD11 | K051535 | 000 |