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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 K991275
Device Name WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
Applicant
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Applicant Contact JOHN MCINROY
Correspondent
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Correspondent Contact JOHN MCINROY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/14/1999
Decision Date 07/01/1999
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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