Device Classification Name |
Speculum, Vaginal, Nonmetal
|
510(k) Number |
K002912 |
Device Name |
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 |
Applicant |
STERINC |
3520 W. WARNER AVE. |
SANTA ANTA,
CA
92704
|
|
Applicant Contact |
TODD ABRAHAM |
Correspondent |
STERINC |
3520 W. WARNER AVE. |
SANTA ANTA,
CA
92704
|
|
Correspondent Contact |
TODD ABRAHAM |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/18/2000 |
Decision Date | 02/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|