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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat Source For Bleaching Teeth
510(k) Number K895174
Device Name UNION BROACH BLEACHING LIGHT
Applicant
Union Broach, Div. Moyco Industries, Inc.
P.O. Box 508
Aberdeen Rd.
Emigsville,  PA  17318
Applicant Contact ALAN P SCHWARTZ
Correspondent
Union Broach, Div. Moyco Industries, Inc.
P.O. Box 508
Aberdeen Rd.
Emigsville,  PA  17318
Correspondent Contact ALAN P SCHWARTZ
Regulation Number872.6475
Classification Product Code
EEG  
Date Received08/07/1989
Decision Date 04/13/1990
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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