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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 K160410
Device Name WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head
Applicant
Dental Savings Club
31 Serge Garant
Montreal,  CA h3E 0A6
Applicant Contact Chadi Saade
Correspondent
Qualmed Corporation
23 Forestview Dr.
Cambridge,  CA N1T1V1
Correspondent Contact Gordon Wehner
Regulation Number872.4200
Classification Product Code
EFB  
Date Received02/16/2016
Decision Date 09/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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