Device Classification Name |
Speculum, Vaginal, Nonmetal
|
510(k) Number |
K003540 |
Device Name |
(DISPOSABLE) VAGINAL SPECULUM |
Applicant |
FEMINICA, INC. |
3216 MONSABRE |
MONTREAL, QUEBEC,
CA
H1N 2L5
|
|
Applicant Contact |
DENIS H DUBOIS |
Correspondent |
FEMINICA, INC. |
3216 MONSABRE |
MONTREAL, QUEBEC,
CA
H1N 2L5
|
|
Correspondent Contact |
DENIS H DUBOIS |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 11/16/2000 |
Decision Date | 02/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|