FDA 510(k) Application Details - K961982

Device Classification Name Stopcock, I.V. Set

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510(K) Number K961982
Device Name Stopcock, I.V. Set
Applicant NORTH, INC.
303 WASHINGTON, SUITE B
NORTHFIELD, MN 55057 US
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Contact JIM POKORNEY
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Regulation Number 880.5440

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Classification Product Code FMG
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Date Received 05/20/1996
Decision Date 02/21/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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