FDA 510(k) Application Details - K130245

Device Classification Name Stopcock, I.V. Set

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510(K) Number K130245
Device Name Stopcock, I.V. Set
Applicant BAXTER HEALTHCARE CORP.
32650 N WILSON RD.
ROUND LAKE, IL 60073-0490 US
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Contact NANETTE HEDDEN
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Regulation Number 880.5440

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Classification Product Code FMG
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Date Received 01/31/2013
Decision Date 03/01/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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