Device Classification Name |
Speculum, Vaginal, Nonmetal
|
510(k) Number |
K880588 |
Device Name |
AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 |
Applicant |
C.I.S.A. IMPORT EXPORT C/O LARSON AND TAYLOR |
9 EAST 41ST ST. |
NEW YORK,
NY
10017
|
|
Applicant Contact |
VICTOR CORBO |
Correspondent |
C.I.S.A. IMPORT EXPORT C/O LARSON AND TAYLOR |
9 EAST 41ST ST. |
NEW YORK,
NY
10017
|
|
Correspondent Contact |
VICTOR CORBO |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 02/11/1988 |
Decision Date | 12/20/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|