Device Classification Name |
pump, breast, non-powered
|
510(k) Number |
K912355 |
Device Name |
MOTHERS TOUCH ONE HAND BREAST PUMP |
Applicant |
HOLLISTER, INC. |
C/O BURDIT,RADZIUS,CHARTERED |
333 W.WACKER DR. |
CHICAGO,
IL
60606
|
|
Applicant Contact |
JOHM F.LEMKER |
Correspondent |
HOLLISTER, INC. |
C/O BURDIT,RADZIUS,CHARTERED |
333 W.WACKER DR. |
CHICAGO,
IL
60606
|
|
Correspondent Contact |
JOHM F.LEMKER |
Regulation Number | 884.5150
|
Classification Product Code |
|
Date Received | 05/28/1991 |
Decision Date | 12/10/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|