The following data is part of a premarket notification filed by Satelec with the FDA for Piezotome.
| Device ID | K060275 |
| 510k Number | K060275 |
| Device Name: | PIEZOTOME |
| Classification | Scaler, Ultrasonic |
| Applicant | SATELEC 130 GAITHER DRIVE SUITE 100 Mt. Laurel, NJ 08054 |
| Contact | Steve Salesky |
| Correspondent | Steve Salesky SATELEC 130 GAITHER DRIVE SUITE 100 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 | 2006-02-02 |
| Decision Date | 2006-05-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PIEZOTOME 79025653 3318536 Live/Registered |
Société pour la Conception des; Applications des Techniques Electroniques -; SATELEC (SAS) 2006-05-13 |