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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 K081425
Device Name COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
Applicant
COOK VASCULAR, INC.
1186 MONTGOMERY LANE
VANDERGRIFT,  PA  15690
Applicant Contact JIM FERGUSON
Correspondent
COOK VASCULAR, INC.
1186 MONTGOMERY LANE
VANDERGRIFT,  PA  15690
Correspondent Contact JIM FERGUSON
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/21/2008
Decision Date 09/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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