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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 K991363
Device Name 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
Applicant
Sorenson Medical, Inc.
1375 W. 8040 S.
West Jordan,  UT  84088 -8320
Applicant Contact R. DOUGLAS JACOB
Correspondent
Sorenson Medical, Inc.
1375 W. 8040 S.
West Jordan,  UT  84088 -8320
Correspondent Contact R. DOUGLAS JACOB
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/20/1999
Decision Date 05/13/1999
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
Predetermined Change
Control Plan Authorized		 No
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