The following data is part of a premarket notification filed by Defiance Electronics, Inc. with the FDA for Air Compressor, Model Pac 6.7.
Device ID | K934815 |
510k Number | K934815 |
Device Name: | AIR COMPRESSOR, MODEL PAC 6.7 |
Classification | Unit, Operative Dental |
Applicant | DEFIANCE ELECTRONICS, INC. 6206 HWY. 11 EAST LENOIR CITY, TN 37771 |
Contact | AVERY NORWOOD |
Correspondent | AVERY NORWOOD DEFIANCE ELECTRONICS, INC. 6206 HWY. 11 EAST LENOIR CITY, TN 37771 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-05 |
Decision Date | 1994-02-01 |