Device Classification Name |
stent, vaginal
|
510(k) Number |
K920633 |
FOIA Releasable 510(k) |
K920633
|
Device Name |
PESSARY FLEXIBLE SILICONE NICHOLS |
Applicant |
BIOTEQUE AMERICA, INC. |
340 E. MAPLE AVE. |
SUITE 102 |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
DENNIS DORSEY |
Correspondent |
BIOTEQUE AMERICA, INC. |
340 E. MAPLE AVE. |
SUITE 102 |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
DENNIS DORSEY |
Regulation Number | 884.3900
|
Classification Product Code |
|
Date Received | 02/12/1992 |
Decision Date | 11/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|