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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 K060119
Device Name MCKINLEY SATURATION CATHETER
Applicant
MCKINLEY MEDICAL LLC
4080 YOUNGFIELD
WHEAT RIDGE,  CO  80033
Applicant Contact JOHN CHAPPELL
Correspondent
MCKINLEY MEDICAL LLC
4080 YOUNGFIELD
WHEAT RIDGE,  CO  80033
Correspondent Contact JOHN CHAPPELL
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/17/2006
Decision Date 04/12/2006
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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