Device Classification Name |
pump, breast, non-powered
|
510(k) Number |
K925738 |
Device Name |
WHITE RIVER MANUAL BREAST PUMP |
Applicant |
WHITE RIVER (TM) |
23010 LAKE FOREST DRIVE, #310 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
CHRISTOPHER SUTTON |
Correspondent |
WHITE RIVER (TM) |
23010 LAKE FOREST DRIVE, #310 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
CHRISTOPHER SUTTON |
Regulation Number | 884.5150
|
Classification Product Code |
|
Date Received | 11/13/1992 |
Decision Date | 05/04/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|