Device Classification Name |
instrument, manual, general obstetric-gynecologic
|
510(k) Number |
K863610 |
Device Name |
THE OB-GYN CONCEPTS VAGINAL ASPIRATOR |
Applicant |
OB/GYN CONCEPTS, LTD. |
613 DOCK DR. |
BARRINGTON,
IL
60010
|
|
Applicant Contact |
CHARLES B ROOT |
Correspondent |
OB/GYN CONCEPTS, LTD. |
613 DOCK DR. |
BARRINGTON,
IL
60010
|
|
Correspondent Contact |
CHARLES B ROOT |
Regulation Number | 884.4520
|
Classification Product Code |
|
Date Received | 09/16/1986 |
Decision Date | 01/07/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|