Device Classification Name |
Pump, Breast, Non-Powered
|
510(k) Number |
K011519 |
Device Name |
AMEDA HYGIENIKIT |
Applicant |
HOLLISTER, INC. |
2000 HOLLISTER DR. |
LIBERTYVILLE,
IL
60048
|
|
Applicant Contact |
JOSEPH S TOKARZ |
Correspondent |
HOLLISTER, INC. |
2000 HOLLISTER DR. |
LIBERTYVILLE,
IL
60048
|
|
Correspondent Contact |
JOSEPH S TOKARZ |
Regulation Number | 884.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/17/2001 |
Decision Date | 08/15/2001 |
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
|
|
|