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FDA 510(k) Application Details - K993592
Device Classification Name
Catheter, Conduction, Anesthetic
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510(K) Number
K993592
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
10/22/1999
Decision Date
05/17/2000
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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