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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K961982
Device Name TRI-FLOW THREE WAY STOPCOCK
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 Number880.5440
Classification Product Code
FMG  
Date Received05/20/1996
Decision Date 02/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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