Device Classification Name |
Pessary, Vaginal
|
510(k) Number |
K920187 |
Device Name |
FLEXIBLE SILICONE GELIHORN |
Applicant |
BIOTEQUE AMERICA, INC. |
51 RAINLILY RD. |
LEVITTOWN,
PA
19056
|
|
Applicant Contact |
DENIS DORSEY |
Correspondent |
BIOTEQUE AMERICA, INC. |
51 RAINLILY RD. |
LEVITTOWN,
PA
19056
|
|
Correspondent Contact |
DENIS DORSEY |
Regulation Number | 884.3575
|
Classification Product Code |
|
Date Received | 01/14/1992 |
Decision Date | 10/23/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|