The following data is part of a premarket notification filed by Evenflo Co., Inc. with the FDA for Evenflo Comfort Control Breast Pump, Evenflo Comfort Control Dual Breast Pump.
| Device ID | K983776 |
| 510k Number | K983776 |
| Device Name: | EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL 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 | 1998-10-26 |
| Decision Date | 1999-04-26 |
| Summary: | summary |