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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 K822636
Device Name CLASS II DEVICE FOR I.C.P. MONITORING
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 Received08/31/1982
Decision Date 09/14/1982
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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