FDA 510(k) Application Details - K122027

Device Classification Name Anesthesia Conduction Kit

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510(K) Number K122027
Device Name Anesthesia Conduction Kit
Applicant ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
READING, PA 19605 US
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Contact PAUL AMUDALA
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Regulation Number 868.5140

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Classification Product Code CAZ
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Date Received 07/11/2012
Decision Date 08/28/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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