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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 K041714
Device Name E-PAIN CARE
Applicant
Breg, Inc.
2611 Commerce Way
Vista,  CA  92083
Applicant Contact KATHLEEN BARBER
Correspondent
Breg, Inc.
2611 Commerce Way
Vista,  CA  92083
Correspondent Contact KATHLEEN BARBER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/23/2004
Decision Date 10/01/2004
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
Predetermined Change
Control Plan Authorized		 No
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