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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K965238
Device Name T1 CONTROL HIGH SPEED DENTAL HANDPIECE
Applicant
Siemens AG
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DIANE E MINEAR
Correspondent
Siemens AG
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DIANE E MINEAR
Regulation Number872.4200
Classification Product Code
EFA  
Date Received12/31/1996
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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