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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K964439
Device Name NEEDLE-FREE VALVED CONNECTOR AND CAP
Applicant
Bmw Medical, Inc.
3598 W. 1820 S.
Salt Lake City,  UT  84104 -4959
Applicant Contact ROGER L RICHINS
Correspondent
Bmw Medical, Inc.
3598 W. 1820 S.
Salt Lake City,  UT  84104 -4959
Correspondent Contact ROGER L RICHINS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/06/1996
Decision Date 07/16/1997
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
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