The following data is part of a premarket notification filed by Cefla S.c.r.l. with the FDA for C-u2.
| Device ID | K062897 |
| 510k Number | K062897 |
| Device Name: | C-U2 |
| Classification | Unit, Operative Dental |
| Applicant | CEFLA S.C.R.L. 110 E GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin CEFLA S.C.R.L. 110 E GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-27 |
| Decision Date | 2006-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033837930174 | K062897 | 000 |