The following data is part of a premarket notification filed by Cefla S.c.r.l. with the FDA for Wds, Size 2 And Size 2.
| Device ID | K061114 |
| 510k Number | K061114 |
| Device Name: | WDS, SIZE 2 AND SIZE 2 |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-21 |
| Decision Date | 2006-06-06 |
| Summary: | summary |