The following data is part of a premarket notification filed by Satelec with the FDA for Surpasson P5 Newtron.
| Device ID | K050895 |
| 510k Number | K050895 |
| Device Name: | SURPASSON P5 NEWTRON |
| Classification | Scaler, Ultrasonic |
| Applicant | SATELEC 17 AVENUE GUSTAVE EIFFEL Z.I. DU PHARE BP 216 Merignac, Gironde, FR 33708 |
| Contact | Pascal Dupeyron |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-08 |
| Decision Date | 2005-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205019202 | K050895 | 000 |
| 00883205019196 | K050895 | 000 |