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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, intravascular
510(k) Number K954433
Device Name VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
Applicant
GISH BIOMEDICAL, INC.
2681 KELVIN AVE.
IRVINE,  CA  92614 -5821
Applicant Contact DEBRA J KRIDNER
Correspondent
GISH BIOMEDICAL, INC.
2681 KELVIN AVE.
IRVINE,  CA  92614 -5821
Correspondent Contact DEBRA J KRIDNER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/25/1995
Decision Date 11/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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