Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K013817 |
Device Name |
GLO-SPEC |
Applicant |
SOL WEISS MD INC |
7012 RESEDA BLVD. |
SUITE A |
RESEDA,
CA
91335
|
|
Applicant Contact |
SOL WEISS |
Correspondent |
SOL WEISS MD INC |
7012 RESEDA BLVD. |
SUITE A |
RESEDA,
CA
91335
|
|
Correspondent Contact |
SOL WEISS |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 11/16/2001 |
Decision Date | 12/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|