The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Cavi-med.
Device ID | K842581 |
510k Number | K842581 |
Device Name: | CAVI-MED |
Classification | Scaler, Ultrasonic |
Applicant | COOPER LASERSONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELC |
CFR Regulation Number | 872.4850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-03 |
Decision Date | 1984-08-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CAVI-MED 74039128 1671050 Dead/Cancelled |
DENTSPLY INTERNATIONAL INC. 1990-03-16 |