The following data is part of a premarket notification filed by Julie Alliance with the FDA for Smilie Pc.
| Device ID | K001445 |
| 510k Number | K001445 |
| Device Name: | SMILIE PC |
| Classification | Unit, Operative Dental |
| Applicant | JULIE ALLIANCE 110 EAST GRANADA BLVD. SUITE 208 P.O. BOX 36 Ormond Beach, FL 32175 -0036 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin JULIE ALLIANCE 110 EAST GRANADA BLVD. SUITE 208 P.O. BOX 36 Ormond Beach, FL 32175 -0036 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-08 |
| Decision Date | 2000-07-26 |