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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 K020988
Device Name PAIN CARE 4200
Original Applicant
BREG, INC.
2611 commerce way
vista,  CA  92083
Original Contact kathleen barber
Regulation Number880.5725
Classification Product Code
MEB  
Date Received03/27/2002
Decision Date 04/04/2002
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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