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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 K061581
Device Name EXCEL HIGH SPEED DENTAL HANDPIECE
Applicant
Orthosource, Inc.
13343 Sherman Way
North Hollywood,  CA  91605
Applicant Contact LLOYD TAYLOR
Correspondent
Orthosource, Inc.
13343 Sherman Way
North Hollywood,  CA  91605
Correspondent Contact LLOYD TAYLOR
Regulation Number872.4200
Classification Product Code
EFA  
Date Received06/07/2006
Decision Date 08/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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