Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K140679 |
Device Name |
SUREFLEX LITHOTRIPSY LASER FIBERS |
Applicant |
AMERICAN MEDICAL SYSTEMS |
3070 ORCHARD DRIVE |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
JOSH CLARIN |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/18/2014 |
Decision Date | 06/20/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|