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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Withdrawal/Infusion Pump
510(k) Number K935763
Device Name SURGIPUMP
Applicant
W.O.M. World of Medicine GmbH
C/O Qualitivity
8536 Calle Tioga
Tucson,  AZ  85704
Applicant Contact OWEN B LAMB
Correspondent
W.O.M. World of Medicine GmbH
C/O Qualitivity
8536 Calle Tioga
Tucson,  AZ  85704
Correspondent Contact OWEN B LAMB
Regulation Number870.1800
Classification Product Code
DQI  
Date Received11/26/1993
Decision Date 04/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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