The following data is part of a premarket notification filed by Cefla S.c.r.l. with the FDA for Rx Dc X-ray Unit.
| Device ID | K080076 |
| 510k Number | K080076 |
| Device Name: | RX DC X-RAY UNIT |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | CEFLA S.C.R.L. 110 E GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude Bertoin |
| Correspondent | Claude Bertoin CEFLA S.C.R.L. 110 E GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-11 |
| Decision Date | 2008-03-14 |