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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shunt, central nervous system and components
510(k) Number K984583
Device Name THE BIOPLATE SHUNT CONNECTOR
Applicant
BIOMEDICS
536 RIMPAU BLVD.
LOS ANGELES,  CA  90020
Applicant Contact ERIC V HOHENSTEIN
Correspondent
BIOMEDICS
536 RIMPAU BLVD.
LOS ANGELES,  CA  90020
Correspondent Contact ERIC V HOHENSTEIN
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/24/1998
Decision Date 03/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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