The following data is part of a premarket notification filed by Advanced Technology Research (a.t.r.) S.r.l. with the FDA for Atr 5000, Lc 5000, Implant System.
| Device ID | K033597 |
| 510k Number | K033597 |
| Device Name: | ATR 5000, LC 5000, IMPLANT SYSTEM |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. VIA GIOVANNI VERGA, 7 Pistoia, IT 51100 |
| Contact | Daniele Poli |
| Correspondent | Elizabeth Drew UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-11-14 |
| Decision Date | 2003-11-25 |
| Summary: | summary |