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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K895985
Device Name SANI-PIKS DENTAL HAND INSTRUMENT
Applicant
Bison-Lee Co.
P.O. Box 26178
Tempe,  AZ  85285
Applicant Contact B PIZZICONI
Correspondent
Bison-Lee Co.
P.O. Box 26178
Tempe,  AZ  85285
Correspondent Contact B PIZZICONI
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received10/13/1989
Decision Date 01/10/1990
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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