The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Quattrocare.
Device ID | K012308 |
510k Number | K012308 |
Device Name: | KAVO QUATTROCARE |
Classification | Handpiece, Air-powered, Dental |
Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
Contact | John Westermeier |
Correspondent | John Westermeier KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-23 |
Decision Date | 2002-06-26 |
Summary: | summary |