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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K896046
Device Name VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
Applicant
Vitaphore Corp.
1505 O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact SOPHIA PESOTCHINSKY
Correspondent
Vitaphore Corp.
1505 O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact SOPHIA PESOTCHINSKY
Regulation Number880.5210
Classification Product Code
KMK  
Date Received10/17/1989
Decision Date 01/11/1990
Decision Substantially Equivalent (SESE)
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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