FDA 510(k) Application Details - K971851

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K971851
Device Name Catheter, Conduction, Anesthetic
Applicant AXIOM MEDICAL, INC.
555 WEST VICTORIA ST.
RANCHO DOMINGUEZ, CA 90220 US
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Contact RIDWAN HARDY
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 05/20/1997
Decision Date 01/22/1998
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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