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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K954189
Device Name EASI-JECTOR CONTROL SYSTEM
Applicant
North, Inc.
303 Washington, Suite B
Northfield,  MN  55057
Applicant Contact JIM POKORNEY
Correspondent
North, Inc.
303 Washington, Suite B
Northfield,  MN  55057
Correspondent Contact JIM POKORNEY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/06/1995
Decision Date 10/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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