FDA 510(k) Application Details - K954970

Device Classification Name Stopcock, I.V. Set

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510(K) Number K954970
Device Name Stopcock, I.V. Set
Applicant MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 40316 US
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Contact JOHN C TOOMEY
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Regulation Number 880.5440

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Classification Product Code FMG
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Date Received 10/30/1995
Decision Date 04/22/1996
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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