Device Classification Name |
System, Assisted Reproduction Laser
|
510(k) Number |
K063636 |
Device Name |
ZILOS-TK |
Applicant |
HAMILTON THORNE BIOSCIENCES |
100 CUMMINGS CENTER, |
SUITE 465E |
BEVERLY,
MA
01915
|
|
Applicant Contact |
DOUGLAS HAMILTON |
Correspondent |
HAMILTON THORNE BIOSCIENCES |
100 CUMMINGS CENTER, |
SUITE 465E |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
DOUGLAS HAMILTON |
Regulation Number | 884.6200
|
Classification Product Code |
|
Date Received | 12/07/2006 |
Decision Date | 04/24/2007 |
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
|
|
|