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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 K983454
Device Name PAIN CARE 2000
Original Applicant
BREG, INC.
2611 commerce way
vista,  CA  92083
Original Contact kathleen barber
Regulation Number880.5725
Classification Product Code
MEB  
Date Received09/30/1998
Decision Date 12/16/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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