The following data is part of a premarket notification filed by Evenflo Co., Inc. with the FDA for Evenflo Soft-touch Ultra Battery Operated Breast Pump.
| Device ID | K960726 |
| 510k Number | K960726 |
| Device Name: | EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | EVENFLO CO., INC. 1333 NEW HAMPSHIRE AVE., N.W. SUITE 400 Washington, DC 20036 |
| Contact | Donald E Segal |
| Correspondent | Donald E Segal EVENFLO CO., INC. 1333 NEW HAMPSHIRE AVE., N.W. SUITE 400 Washington, DC 20036 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-22 |
| Decision Date | 1996-07-22 |