Device Classification Name |
Instrument, Manual, Specialized Obstetric-Gynecologic
|
510(k) Number |
K871069 |
Device Name |
MODIFIED HYSTEROSALPINGOGRAPY SET |
Applicant |
ACKRAD LABORATORIES |
70 JACKSON DR. |
CRANFORD,
NJ
07016
|
|
Applicant Contact |
BERNARD ACKERMAN,PHD |
Correspondent |
ACKRAD LABORATORIES |
70 JACKSON DR. |
CRANFORD,
NJ
07016
|
|
Correspondent Contact |
BERNARD ACKERMAN,PHD |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 03/18/1987 |
Decision Date | 04/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|