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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K063007
Device Name POWERTOME PERIOTOME
Applicant
Westport Medical, Inc.
6603 Rippling Brook Dr. SE
Salem,  OR  97317
Applicant Contact RALPH WELLS
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MICHELLE LEE
Regulation Number872.4200
Classification Product Code
EKX  
Date Received10/02/2006
Decision Date 10/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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