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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 K142063
Device Name #8C RENEGADE DENTAL HANDPIECE
Applicant
HANDPIECE CLUB, LLC
62 FOREST STREET, SUITE 300
MARLBOROUGH,  MA  01752
Applicant Contact TINA WU
Correspondent
HANDPIECE CLUB, LLC
62 FOREST STREET, SUITE 300
MARLBOROUGH,  MA  01752
Correspondent Contact TINA WU
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/30/2014
Decision Date 10/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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