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FDA 510(k) Application Details - K153469
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
More FDA Info for this Device
510(K) Number
K153469
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
L&Z US, INC.
6 HORIZON ROAD, #2301
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
12/01/2015
Decision Date
09/01/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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