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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 K954123
Device Name LOW PROFILE SAFSITE Y-SITE
Original Applicant
B. BRAUN MEDICAL, INC.
824 twelfth ave.
bethlehem,  PA  18018
Original Contact mark s alsberge
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/01/1995
Decision Date 11/21/1995
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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