Device Classification Name |
system, assisted reproduction laser
|
510(k) Number |
K120055 |
Device Name |
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS |
Applicant |
HAMILTON THORNE, INC. |
100 CUMMINGS CENTER-SUITE 465E |
Beverly,
MA
01915
|
|
Applicant Contact |
DIARMAID H DOUGLAS-HAMILTON |
Correspondent |
HAMILTON THORNE, INC. |
100 CUMMINGS CENTER-SUITE 465E |
Beverly,
MA
01915
|
|
Correspondent Contact |
DIARMAID H DOUGLAS-HAMILTON |
Regulation Number | 884.6200
|
Classification Product Code |
|
Date Received | 01/09/2012 |
Decision Date | 04/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|