Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K133281
Device Classification Name
More FDA Info for this Device
510(K) Number
K133281
Device Name
NEOTRACT UROLIFT SYSTEM
Applicant
NEOTRACT, INC.
4473 WILLOW ROAD
SUITE 100
PLEASANTON, CA 94588 US
Other 510(k) Applications for this Company
Contact
Nancy E Isaac
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/25/2013
Decision Date
12/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact