The following data is part of a premarket notification filed by Evenflo Company, Inc. with the FDA for Evenflo Comfort Ease Manual Breast Pump Kit.
| Device ID | K013226 |
| 510k Number | K013226 |
| Device Name: | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT |
| Classification | Pump, Breast, Non-powered |
| Applicant | EVENFLO COMPANY, INC. 1000 EVENFLO DR. P.O. BOX 709 Canton, GA 30114 |
| Contact | Matthew G Mccarty |
| Correspondent | Matthew G Mccarty EVENFLO COMPANY, INC. 1000 EVENFLO DR. P.O. BOX 709 Canton, GA 30114 |
| Product Code | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-27 |
| Decision Date | 2001-12-20 |