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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Analytical Sampling
510(k) Number K920438
Device Name VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM
Applicant
VIA MEDICAL CORP.
10633 ROSELLE ST.
SAN DIEGO,  CA  92121
Applicant Contact DAN MCKAY
Correspondent
VIA MEDICAL CORP.
10633 ROSELLE ST.
SAN DIEGO,  CA  92121
Correspondent Contact DAN MCKAY
Regulation Number880.5725
Classification Product Code
LZF  
Date Received02/03/1992
Decision Date 10/22/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
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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