Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K132655
Device Classification Name
More FDA Info for this Device
510(K) Number
K132655
Device Name
RETROARC RETROPUBIC SLING SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
Other 510(k) Applications for this Company
Contact
RENEE MELLUM
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/26/2013
Decision Date
11/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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