The following data is part of a premarket notification filed by Satelec-acteon Group with the FDA for Implant Center.
| Device ID | K072030 |
| 510k Number | K072030 |
| Device Name: | IMPLANT CENTER |
| Classification | Drill, Bone, Powered |
| Applicant | SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 Mt Laurel, NJ 08054 |
| Contact | Steve Salesky |
| Correspondent | Steve Salesky SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 Mt Laurel, NJ 08054 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-24 |
| Decision Date | 2007-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03609820573762 | K072030 | 000 |
| 03609820573748 | K072030 | 000 |
| 03609820573700 | K072030 | 000 |