The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Planmeca Prosensor.
| Device ID | K091197 |
| 510k Number | K091197 |
| Device Name: | PLANMECA PROSENSOR |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PLANMECA OY 100 NORTH GARY AVE. SUITE A Roselle, IL 60172 |
| Contact | Bob Pienkowski |
| Correspondent | Bob Pienkowski PLANMECA OY 100 NORTH GARY AVE. SUITE A Roselle, IL 60172 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035420308 | K091197 | 000 |