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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
Applicant
BREG, INC.
2611 commerce way
vista,  CA  92083
Applicant Contact kathleen barber
Correspondent
BREG, INC.
2611 commerce way
vista,  CA  92083
Correspodent 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
Type Special
Reviewed by Third Party No
Combination Product No
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