FDA 510(k) Application Details - K974083

Device Classification Name Stopcock, I.V. Set

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510(K) Number K974083
Device Name Stopcock, I.V. Set
Applicant OHMEDA MEDICAL
100 MOUNTAIN AVE.
MURRAY HILL, NJ 07974-2005 US
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Contact JING ZHANG
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Regulation Number 880.5440

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Classification Product Code FMG
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Date Received 10/29/1997
Decision Date 01/13/1998
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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