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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K872998
Device Name VITAACCESS (TM) CATHETER INTRODUCER SYSTEM
Applicant
VITAPHORE CORP.
887 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Applicant Contact SOPHIA PESOTCHINSKY
Correspondent
VITAPHORE CORP.
887 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Correspondent Contact SOPHIA PESOTCHINSKY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/03/1987
Decision Date 03/24/1988
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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