The following data is part of a premarket notification filed by Evenflo Company, Inc. with the FDA for Evenflo Comfort Select Auto-cycle Breast Pump Kit.
| Device ID | K022933 |
| 510k Number | K022933 |
| Device Name: | EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT |
| Classification | Pump, Breast, Powered |
| Applicant | EVENFLO COMPANY, INC. 707 CROSSROADS COURT Vandalia, OH 45377 |
| Contact | Matthew G Mccarty |
| Correspondent | Matthew G Mccarty EVENFLO COMPANY, INC. 707 CROSSROADS COURT Vandalia, OH 45377 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-04 |
| Decision Date | 2002-12-02 |
| Summary: | summary |