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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, monitoring, intracranial pressure
510(k) Number K032337
Device Name HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
Applicant
HEMEDEX INCORPORATED
7 TIFFANY TRAIL
HOPKINTON,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
HEMEDEX INCORPORATED
7 TIFFANY TRAIL
HOPKINTON,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number882.1620
Classification Product Code
GWM  
Date Received07/29/2003
Decision Date 10/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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