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FDA 510(k) Application Details - K150789
Device Classification Name
Catheter, Conduction, Anesthetic
More FDA Info for this Device
510(K) Number
K150789
Device Name
Catheter, Conduction, Anesthetic
Applicant
IMEDICOM CO., LTD.
#612, 172, LS-ro
Gunpo-si 435-824 KR
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Contact
Bonngu Ha
Other 510(k) Applications for this Contact
Regulation Number
868.5120
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Classification Product Code
BSO
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More FDA Info for this Product Code
Date Received
03/25/2015
Decision Date
03/01/2016
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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