The following data is part of a premarket notification filed by Whisper Wear with the FDA for Whisper Wear Breast Pump.
| Device ID | K022140 |
| 510k Number | K022140 |
| Device Name: | WHISPER WEAR BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | WHISPER WEAR 19526 EAST LAKE DR. Miami, FL 33015 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn WHISPER WEAR 19526 EAST LAKE DR. Miami, FL 33015 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2002-09-30 |
| Summary: | summary |