The following data is part of a premarket notification filed by Satelec-acteon Group with the FDA for Newtron Booster.
| Device ID | K131997 |
| 510k Number | K131997 |
| Device Name: | NEWTRON BOOSTER |
| Classification | Scaler, Ultrasonic |
| Applicant | SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 Mt Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 Mt Laurel, NJ 08054 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2013-11-26 |
| Summary: | summary |