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 |