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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 K090369
Device Name PRODRIVE LINE OF DENTAL HANDPIECES
Applicant
PRODRIVE SYSTEMS, INC.
812 COMMERCE DR.
OGDENSBURG,  NY  13669
Applicant Contact TIMOTHY F NASON
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.4200
Classification Product Code
EFB  
Date Received02/13/2009
Decision Date 02/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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