The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Systematica 1060.
Device ID | K940950 |
510k Number | K940950 |
Device Name: | KAVO SYSTEMATICA 1060 |
Classification | Chair, Dental, With Operative Unit |
Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
Contact | Edward Stogenson |
Correspondent | Edward Stogenson KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-28 |
Decision Date | 1994-12-29 |