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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 K840999
Device Name PHILLY INFANT BOLT
Applicant
PHILADELPHIA MEDICAL SPECIALTIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHILADELPHIA MEDICAL SPECIALTIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1620
Classification Product Code
GWM  
Date Received03/09/1984
Decision Date 04/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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