The following data is part of a premarket notification filed by White River (tm) with the FDA for White River Manual Breast Pump.
Device ID | K925738 |
510k Number | K925738 |
Device Name: | WHITE RIVER MANUAL BREAST PUMP |
Classification | Pump, Breast, Non-powered |
Applicant | WHITE RIVER (TM) 23010 LAKE FOREST DRIVE, #310 Laguna Hills, CA 92653 |
Contact | Christopher Sutton |
Correspondent | Christopher Sutton WHITE RIVER (TM) 23010 LAKE FOREST DRIVE, #310 Laguna Hills, CA 92653 |
Product Code | HGY |
CFR Regulation Number | 884.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-13 |
Decision Date | 1994-05-04 |