Device Classification Name |
led light source
|
510(k) Number |
K113679 |
Device Name |
LUCEA LED SURGICAL LIGHT SYSTEM |
Applicant |
MAQUET SAS |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Applicant Contact |
WHITNEY TORNING |
Correspondent |
MAQUET SAS |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
WHITNEY TORNING |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/14/2011 |
Decision Date | 01/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|