Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K973853 |
Device Name |
KOLPLAST VAGINAL SPECULUM |
Applicant |
KOLPLAST COMERCIAL E INDUSTRIAL LTDA |
P.O BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
E J SMITH |
Correspondent |
KOLPLAST COMERCIAL E INDUSTRIAL LTDA |
P.O BOX 4341 |
CROFTON,
MD
21114
|
|
Correspondent Contact |
E J SMITH |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 10/08/1997 |
Decision Date | 12/19/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|