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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
Applicant
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Applicant Contact SUZANNE DENNIS
Correspondent
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Correspondent 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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