Device Classification Name |
Speculum, Vaginal, Metal
|
510(k) Number |
K851799 |
Device Name |
61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA |
Applicant |
ARTIBERIA |
4518 LOS RANCHITOS |
SAN ANTONIO,
TX
78233
|
|
Applicant Contact |
GIL M SANCHEZ |
Correspondent |
ARTIBERIA |
4518 LOS RANCHITOS |
SAN ANTONIO,
TX
78233
|
|
Correspondent Contact |
GIL M SANCHEZ |
Regulation Number | 884.4520
|
Classification Product Code |
|
Date Received | 04/25/1985 |
Decision Date | 05/22/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|