Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K162445 |
Device Name |
LiVac Retractor System |
Applicant |
Livac Pty Ltd |
8 Melaleuca Court |
Warrnambool,
AU
3280
|
|
Applicant Contact |
Anabela Correia |
Correspondent |
Emergo Global |
2500 Bee Cave, Bldg 1, Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
Stuart R. Goldman |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/31/2016 |
Decision Date | 10/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|