Device Classification Name |
Speculum, Vaginal, Nonmetal
|
510(k) Number |
K903080 |
Device Name |
DISPOSABLE PLASTIC VAGINAL SPECULUM |
Applicant |
DAWNEX INDUSTRIES, INC. |
861 PARK AVE. |
BROOKLYN,
NY
11206
|
|
Applicant Contact |
WILLIAM PYMM |
Correspondent |
DAWNEX INDUSTRIES, INC. |
861 PARK AVE. |
BROOKLYN,
NY
11206
|
|
Correspondent Contact |
WILLIAM PYMM |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 07/12/1990 |
Decision Date | 09/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|