Device Classification Name |
pump, breast, non-powered
|
510(k) Number |
K823461 |
Device Name |
AXIPUMP MANUAL BREAST PUMP |
Applicant |
D.J. COLGATE MEDICAL, LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
D.J. COLGATE MEDICAL, LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.5150
|
Classification Product Code |
|
Date Received | 11/19/1982 |
Decision Date | 01/18/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|