The following data is part of a premarket notification filed by Planmeca Usa, Inc. with the FDA for Pm2002 Proline.
| Device ID | K923534 |
| 510k Number | K923534 |
| Device Name: | PM2002 PROLINE |
| Classification | Chair, Dental, With Operative Unit |
| Applicant | PLANMECA USA, INC. ASENTAJASNKATU 6 00810 HELSINKI Finland, FI |
| Contact | Ismo Seppa |
| Correspondent | Ismo Seppa PLANMECA USA, INC. ASENTAJASNKATU 6 00810 HELSINKI Finland, FI |
| Product Code | KLC |
| CFR Regulation Number | 872.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1994-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035420162 | K923534 | 000 |