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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K002334
Device Name MACROPORENS CRANILOC
Applicant
Macropore Biosurgery, Inc.
6740 Top Gun St.
San Diego,  CA  92121
Applicant Contact KENNITH K KLEINHENZ
Correspondent
Macropore Biosurgery, Inc.
6740 Top Gun St.
San Diego,  CA  92121
Correspondent Contact KENNITH K KLEINHENZ
Regulation Number882.5250
Classification Product Code
GXR  
Subsequent Product Code
HBW  
Date Received08/01/2000
Decision Date 05/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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