Device Classification Name |
confocal optical imaging
|
510(k) Number |
K120208 |
Device Name |
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES |
Applicant |
MAUNA KEA TECHNOLOGIES |
8 SNOWBERRY COURT |
ORINDA,
CA
94563
|
|
Applicant Contact |
MICHAEL A DANIEL |
Correspondent |
MAUNA KEA TECHNOLOGIES |
8 SNOWBERRY COURT |
ORINDA,
CA
94563
|
|
Correspondent Contact |
MICHAEL A DANIEL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/24/2012 |
Decision Date | 04/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|