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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, Long-Term Greater Than 30 Days
510(k) Number K963097
Device Name CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
Applicant
BMW MEDICAL, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104 -4959
Applicant Contact PHIL TRIOLO
Correspondent
BMW MEDICAL, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104 -4959
Correspondent Contact PHIL TRIOLO
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/09/1996
Decision Date 10/18/1996
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
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