The following data is part of a premarket notification filed by Evenflo Company, Inc. with the FDA for Simplygo Breast Pump.
| Device ID | K102600 |
| 510k Number | K102600 |
| Device Name: | SIMPLYGO BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | EVENFLO COMPANY, INC. 225 BYERS RD. Miamisburg, OH 45342 |
| Contact | Amy Neff |
| Correspondent | Amy Neff EVENFLO COMPANY, INC. 225 BYERS RD. Miamisburg, OH 45342 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2010-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849409000040 | K102600 | 000 |
| 00849409000033 | K102600 | 000 |