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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 K962300
Device Name CLAMPLESS VALVED CATHETER
Applicant
BMW MEDICAL, INC.
5945 SOUTH 350 WEST
MURRAY,  UT  84107
Applicant Contact PHIL TRIOLO, PH.D.
Correspondent
BMW MEDICAL, INC.
5945 SOUTH 350 WEST
MURRAY,  UT  84107
Correspondent Contact PHIL TRIOLO, PH.D.
Regulation Number880.5970
Classification Product Code
LJS  
Date Received06/13/1996
Decision Date 09/05/1996
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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