The following data is part of a premarket notification filed by Cefla S.c. with the FDA for R7.
| Device ID | K130834 |
| 510k Number | K130834 |
| Device Name: | R7 |
| Classification | Scaler, Ultrasonic |
| Applicant | CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2013-10-08 |