Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K170362
Device Classification Name
Stent, Ureteral
More FDA Info for this Device
510(K) Number
K170362
Device Name
Stent, Ureteral
Applicant
Coloplast Corp
1601 West River Road North
Minneapolis, MN 55411 US
Other 510(k) Applications for this Company
Contact
Cori Ragan
Other 510(k) Applications for this Contact
Regulation Number
876.4620
More FDA Info for this Regulation Number
Classification Product Code
FAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/06/2017
Decision Date
11/15/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
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