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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intraventricular
510(k) Number K950315
Device Name CORDIS CSF RESERVOIR
Applicant
CORDIS CORP.
P.O. BOX 025700
MIAMI,  FL  33102
Applicant Contact MARVIN L SUSSMAN
Correspondent
CORDIS CORP.
P.O. BOX 025700
MIAMI,  FL  33102
Correspondent Contact MARVIN L SUSSMAN
Regulation Number882.5550
Classification Product Code
LKG  
Date Received01/26/1995
Decision Date 05/09/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Neurology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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