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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 K912139
Device Name MODEL 704
Applicant
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Applicant Contact STEVEN M.SIMON
Correspondent
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Correspondent Contact STEVEN M.SIMON
Regulation Number882.1620
Classification Product Code
GWM  
Date Received05/14/1991
Decision Date 03/25/1992
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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