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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 K050433
Device Name ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
Applicant
Zimmer Orthopaedic Surgical Products
200 W. Ohio Ave.
P.O. Box 10
Dover,  OH  44622
Applicant Contact CINDY J DICKEY
Correspondent
Zimmer Orthopaedic Surgical Products
200 W. Ohio Ave.
P.O. Box 10
Dover,  OH  44622
Correspondent Contact CINDY J DICKEY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/22/2005
Decision Date 04/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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