Device Classification Name |
System, Assisted Reproduction Laser
|
510(k) Number |
K050768 |
Device Name |
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 |
Applicant |
HAMILTON THORNE BIOSCIENCES |
181 ELLIOTT ST. |
100 CUMMINGS CENTER-SUITE 465E |
BEVERLY,
MA
01915 -6101
|
|
Applicant Contact |
DIARMAID H DOUGLAS-HAMILTON |
Correspondent |
HAMILTON THORNE BIOSCIENCES |
181 ELLIOTT ST. |
100 CUMMINGS CENTER-SUITE 465E |
BEVERLY,
MA
01915 -6101
|
|
Correspondent Contact |
DIARMAID H DOUGLAS-HAMILTON |
Regulation Number | 884.6200
|
Classification Product Code |
|
Date Received | 03/25/2005 |
Decision Date | 04/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|