Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K111118
Device Classification Name
More FDA Info for this Device
510(K) Number
K111118
Device Name
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
Applicant
AMERICAN MEDICAL SYSTEMS
10700 BREN RD WEST
MINNETONKA, MN 55343 US
Other 510(k) Applications for this Company
Contact
MONA INMAN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OTP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/21/2011
Decision Date
07/01/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact