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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 -4908
Applicant Contact ELIZABETH PAUL
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
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
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