Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K160077
Device Classification Name
Catheter, Nephrostomy
More FDA Info for this Device
510(K) Number
K160077
Device Name
Catheter, Nephrostomy
Applicant
JBW7 Innovations, LLC
22200 W. 11 Mile Road, # 4182
Southfield, MI 48037 US
Other 510(k) Applications for this Company
Contact
Jason B Wynberg
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LJE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/14/2016
Decision Date
07/12/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact