Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K943494 |
Device Name |
HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY |
Applicant |
LYCO ENTERPRISES, INC. |
4727 OSBORNE DR., |
BLDG. A, SUITE 100 |
EL PASO,
TX
79922 -1011
|
|
Applicant Contact |
JOHN J O'CONNOR |
Correspondent |
LYCO ENTERPRISES, INC. |
4727 OSBORNE DR., |
BLDG. A, SUITE 100 |
EL PASO,
TX
79922 -1011
|
|
Correspondent Contact |
JOHN J O'CONNOR |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/19/1994 |
Decision Date | 07/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|