Device Classification Name |
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
|
510(k) Number |
K841682 |
Device Name |
UTERINE INJECTOR 4.0MM |
Applicant |
HUMI CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HUMI CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.1300
|
Classification Product Code |
|
Date Received | 04/23/1984 |
Decision Date | 07/03/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|