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FDA 510(k) Application Details - K172039
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
More FDA Info for this Device
510(K) Number
K172039
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
L&Z US, Inc.
6 Horizon Road
Fort Lee, NJ 07024 US
Other 510(k) Applications for this Company
Contact
Jenella Coutts
Other 510(k) Applications for this Contact
Regulation Number
880.5970
More FDA Info for this Regulation Number
Classification Product Code
LJS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2017
Decision Date
08/03/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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