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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K882491
Device Name CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS
Applicant
Steri-Sol, Inc.
132 N. Second St.
Danville,  KY  40422
Applicant Contact THAD J OVERMYER,DMD
Correspondent
Steri-Sol, Inc.
132 N. Second St.
Danville,  KY  40422
Correspondent Contact THAD J OVERMYER,DMD
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/16/1988
Decision Date 08/26/1988
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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