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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 K002321
FOIA Releasable 510(k) K002321
Device Name PAIN CARE 2000L
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
MEB  
Date Received07/31/2000
Decision Date 08/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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