Device Classification Name |
speculum, vaginal, metal
|
510(k) Number |
K862478 |
Device Name |
HAYES VAGINAL SHIELD |
Applicant |
FRANKLIN MEDICAL USA, INC. |
26206 W. 12 MILE RD. |
SUITE 200 |
SOUTHFIELD,
MI
48034
|
|
Applicant Contact |
HAYES, M.D. |
Correspondent |
FRANKLIN MEDICAL USA, INC. |
26206 W. 12 MILE RD. |
SUITE 200 |
SOUTHFIELD,
MI
48034
|
|
Correspondent Contact |
HAYES, M.D. |
Regulation Number | 884.4520
|
Classification Product Code |
|
Date Received | 06/30/1986 |
Decision Date | 11/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|