The following data is part of a premarket notification filed by Defiance Electronics, Inc. with the FDA for Defiance Model Fus 336.
Device ID | K902685 |
510k Number | K902685 |
Device Name: | DEFIANCE MODEL FUS 336 |
Classification | Light, Operating, Dental |
Applicant | DEFIANCE ELECTRONICS, INC. ROUTE 4 BOX 167, HIGHWAY 11 LENOIR CITY, TN 37771 |
Contact | AVERY NORWOOD |
Correspondent | AVERY NORWOOD DEFIANCE ELECTRONICS, INC. ROUTE 4 BOX 167, HIGHWAY 11 LENOIR CITY, TN 37771 |
Product Code | EAZ |
CFR Regulation Number | 872.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-19 |
Decision Date | 1990-09-17 |