Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K853107 |
Device Name |
AXICARE CM-14 AUTOMATIC BREAST PUMP |
Applicant |
CRYSTAL MEDICAL PRODUCTS, INC. |
118 BARRINGTON COMMONS PLAZA |
SUITE 240 |
BARRINGTON,
IL
60010
|
|
Applicant Contact |
WILLIAM J FRAIT |
Correspondent |
CRYSTAL MEDICAL PRODUCTS, INC. |
118 BARRINGTON COMMONS PLAZA |
SUITE 240 |
BARRINGTON,
IL
60010
|
|
Correspondent Contact |
WILLIAM J FRAIT |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 07/23/1985 |
Decision Date | 11/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|