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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, Pca
510(k) Number K020418
Device Name GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
Applicant
P.T. Greenleaf
25 Shann St., Floreat
Perth,  AU 6014
Applicant Contact GEORGE O'NEIL
Correspondent
P.T. Greenleaf
25 Shann St., Floreat
Perth,  AU 6014
Correspondent Contact GEORGE O'NEIL
Regulation Number880.5725
Classification Product Code
MEA  
Date Received02/07/2002
Decision Date 04/29/2003
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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