Device Classification Name |
Lamp, Surgical
|
510(k) Number |
K130513 |
Device Name |
VOLISTA 400; VOLISTA 600 |
Applicant |
MAQUET SAS |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Applicant Contact |
TOSIN YEDESS |
Correspondent |
MAQUET SAS |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
TOSIN YEDESS |
Regulation Number | 878.4580
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/27/2013 |
Decision Date | 05/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|