AIR COMPRESSOR, MODEL PAC 6.7

Unit, Operative Dental

DEFIANCE ELECTRONICS, INC.

The following data is part of a premarket notification filed by Defiance Electronics, Inc. with the FDA for Air Compressor, Model Pac 6.7.

Pre-market Notification Details

Device IDK934815
510k NumberK934815
Device Name:AIR COMPRESSOR, MODEL PAC 6.7
ClassificationUnit, Operative Dental
Applicant DEFIANCE ELECTRONICS, INC. 6206 HWY. 11 EAST LENOIR CITY,  TN  37771
ContactAVERY NORWOOD
CorrespondentAVERY NORWOOD
DEFIANCE ELECTRONICS, INC. 6206 HWY. 11 EAST LENOIR CITY,  TN  37771
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-05
Decision Date1994-02-01

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