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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K971844
Device Name MCKINLEY OUTBOUND-2 SYSTEM
Applicant
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Applicant Contact BRIAN D ZDEB
Correspondent
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Correspondent Contact BRIAN D ZDEB
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/19/1997
Decision Date 01/23/1998
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
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