Device Classification Name |
Speculum, Vaginal, Nonmetal
|
510(k) Number |
K830725 |
Device Name |
GENT-L-SPEC DISPOS. VAGINAL SPECULUM |
Applicant |
GENEVA LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
GENEVA LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 03/08/1983 |
Decision Date | 04/27/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|