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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drills, burrs, trephines & accessories (compound, powered)
510(k) Number K082010
Device Name STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
Applicant
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
CARRIGTWOHILL BUSINESS &
TECHNOLOGY PARK
CARRIGTWOHILL, CO.CORK,  IE
Applicant Contact COLETTE O'CONNOR
Correspondent
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
CARRIGTWOHILL BUSINESS &
TECHNOLOGY PARK
CARRIGTWOHILL, CO.CORK,  IE
Correspondent Contact COLETTE O'CONNOR
Regulation Number882.4305
Classification Product Code
HBF  
Date Received07/15/2008
Decision Date 12/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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