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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 K083101
Device Name PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES
Applicant
SABLE INDUSTRIES, INC.
16576 W. 53rd way
Golden,  CO  80403
Applicant Contact KEVIN RANDALL
Correspondent
SABLE INDUSTRIES, INC.
16576 W. 53rd way
Golden,  CO  80403
Correspondent Contact KEVIN RANDALL
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received10/20/2008
Decision Date 02/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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