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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, elastomeric
510(k) Number K982256
Device Name OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
Original Applicant
MCKINLEY, INC.
4080 youngfield st.
wheat ridge,  CO  80033
Original Contact suzanne dennis
Regulation Number880.5725
Classification Product Code
MEB  
Date Received06/26/1998
Decision Date 09/30/1998
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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