The following data is part of a premarket notification filed by White River Concepts with the FDA for White River Mini Manual Breast Pump.
| Device ID | K971231 |
| 510k Number | K971231 |
| Device Name: | WHITE RIVER MINI MANUAL BREAST PUMP |
| Classification | Pump, Breast, Non-powered |
| Applicant | WHITE RIVER CONCEPTS 924 CALLE NEGOCIO, UNIT C San Clemente, CA 92673 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith WHITE RIVER CONCEPTS 924 CALLE NEGOCIO, UNIT C San Clemente, CA 92673 |
| Product Code | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-03 |
| Decision Date | 1997-05-19 |