The following data is part of a premarket notification filed by White River Concepts with the FDA for White River Automatic Breast Pump.
| Device ID | K964679 |
| 510k Number | K964679 |
| Device Name: | WHITE RIVER AUTOMATIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | WHITE RIVER CONCEPTS 924 C CALLE NEGOCIO San Clemente, CA 92673 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith WHITE RIVER CONCEPTS 924 C CALLE NEGOCIO San Clemente, CA 92673 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-21 |
| Decision Date | 1997-06-10 |