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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 K991897
Device Name CATHETER INNOVATIONS IMPLANTABLE PORT
Applicant
CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact ROGER L RICHINS
Correspondent
CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact ROGER L RICHINS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/04/1999
Decision Date 10/21/1999
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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