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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
Predetermined Change
Control Plan Authorized		 No
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