Device Classification Name |
Electrocautery, Gynecologic (And Accessories)
|
510(k) Number |
K130606 |
Device Name |
FMWAND FERROMAGNETIC SURGICAL SYSTEM |
Applicant |
DOMAIN SURGICAL, INC. |
1370 S 2100 E |
Salt Lake City,
UT
84108
|
|
Applicant Contact |
CURTIS JENSEN |
Correspondent |
DOMAIN SURGICAL, INC. |
1370 S 2100 E |
Salt Lake City,
UT
84108
|
|
Correspondent Contact |
CURTIS JENSEN |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 03/07/2013 |
Decision Date | 01/03/2014 |
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
|
|
|