Device Classification Name |
System, Assisted Reproduction Laser
|
510(k) Number |
K083208 |
Device Name |
SATURN ACTIVE LASER SYSTEM |
Applicant |
RESEARCH INSTRUMENTS LTD. |
BICKLAND INDUSTRIAL PARK |
FALMOUTH, CORNWALL,
GB
TR11 4TA
|
|
Correspondent |
RESEARCH INSTRUMENTS LTD. |
BICKLAND INDUSTRIAL PARK |
FALMOUTH, CORNWALL,
GB
TR11 4TA
|
|
Regulation Number | 884.6200
|
Classification Product Code |
|
Date Received | 10/31/2008 |
Decision Date | 08/25/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|