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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K870797
Device Name PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE
Applicant
Safco Dental Supply
624 W. Adams St.
Chicago,  IL  60606
Applicant Contact HAROLD SAFFIR
Correspondent
Safco Dental Supply
624 W. Adams St.
Chicago,  IL  60606
Correspondent Contact HAROLD SAFFIR
Regulation Number872.4200
Classification Product Code
EKX  
Date Received02/27/1987
Decision Date 05/01/1987
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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