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FDA 510(k) Application Details - K171193
Device Classification Name
Catheter, Conduction, Anesthetic
More FDA Info for this Device
510(K) Number
K171193
Device Name
Catheter, Conduction, Anesthetic
Applicant
Ferrosan Medical Devices SP. Z O.O.
Koksowa 3
Szczecin 70-031 PL
Other 510(k) Applications for this Company
Contact
Elzbieta Porebska-Guillemant
Other 510(k) Applications for this Contact
Regulation Number
868.5120
More FDA Info for this Regulation Number
Classification Product Code
BSO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2017
Decision Date
12/18/2017
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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