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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, elastomeric
510(k) Number K013928
Device Name PAIN CARE 3200
Original Applicant
BREG, INC.
2611 commerce way
vista,  CA  92083
Original Contact kathleen barber
Regulation Number880.5725
Classification Product Code
MEB  
Date Received11/28/2001
Decision Date 12/03/2001
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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