Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K093218 |
Device Name |
FEMEYE TWO |
Applicant |
FEMSUITE, LLC |
19991 7TH STREET EAST |
SONOMA,
CA
95476
|
|
Applicant Contact |
PAVAN SETHI |
Correspondent |
FEMSUITE, LLC |
19991 7TH STREET EAST |
SONOMA,
CA
95476
|
|
Correspondent Contact |
PAVAN SETHI |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 10/13/2009 |
Decision Date | 05/18/2010 |
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
|
|
|