The following data is part of a premarket notification filed by Evenflo Company, Inc. with the FDA for Ameda Platinum Breast Pump.
| Device ID | K100435 |
| 510k Number | K100435 |
| Device Name: | AMEDA PLATINUM BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | EVENFLO COMPANY, INC. 225 BYERS RD. Miamisburg, OH 45342 |
| Contact | Steve Nowak |
| Correspondent | Steve Nowak EVENFLO COMPANY, INC. 225 BYERS RD. Miamisburg, OH 45342 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810725021590 | K100435 | 000 |
| 00810725022603 | K100435 | 000 |
| 00810725023402 | K100435 | 000 |