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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K060260
Device Name MICROPOWER HAND PIECE HIGH SPEED DRILL
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact ELIZABETH PAUL
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact ELIZABETH PAUL
Regulation Number882.4360
Classification Product Code
HBC  
Date Received02/01/2006
Decision Date 04/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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