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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K934815
Device Name AIR COMPRESSOR, MODEL PAC 6.7
Applicant
Defiance Electronics, Inc.
6206 Hwy. 11 E.
Lenoir City,  TN  37771
Applicant Contact AVERY NORWOOD
Correspondent
Defiance Electronics, Inc.
6206 Hwy. 11 E.
Lenoir City,  TN  37771
Correspondent Contact AVERY NORWOOD
Regulation Number872.6640
Classification Product Code
EIA  
Date Received10/05/1993
Decision Date 02/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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