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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Operating, Dental
510(k) Number K902685
Device Name DEFIANCE MODEL FUS 336
Applicant
Defiance Electronics, Inc.
Rte. 4 Box 167, Hwy. 11
Lenoir City,  TN  37771
Applicant Contact AVERY NORWOOD
Correspondent
Defiance Electronics, Inc.
Rte. 4 Box 167, Hwy. 11
Lenoir City,  TN  37771
Correspondent Contact AVERY NORWOOD
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received06/19/1990
Decision Date 09/17/1990
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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