The following data is part of a premarket notification filed by Evenflo Feeding Incorporated with the FDA for Evenflo Advanced Double Electric Breast Pump.
| Device ID | K131153 |
| 510k Number | K131153 |
| Device Name: | EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | EVENFLO FEEDING INCORPORATED 9277 Centre Pointe Dr Ste 160 West Chester, OH 45069 |
| Contact | Wade Halma |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-04-24 |
| Decision Date | 2013-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849409000019 | K131153 | 000 |