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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, infusion
510(k) Number K003611
Device Name PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
Original Applicant
BREG, INC.
2611 commerce way
vista,  CA  92083
Original Contact kathleen barber
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/22/2000
Decision Date 12/13/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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