FDA 510(k) Application Details - K964783

Device Classification Name Anesthesia Conduction Kit

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510(K) Number K964783
Device Name Anesthesia Conduction Kit
Applicant ALEXANDER MEDICAL, INC.
15828 SHADY GROVE RD.
SUITE 130
ROCKVILLE, MD 20841 US
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Contact KENNETH A PALMER
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Regulation Number 868.5140

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Classification Product Code CAZ
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Date Received 11/27/1996
Decision Date 02/12/1997
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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