The following data is part of a premarket notification filed by Gerber Products Co. with the FDA for Gerber Double Electric Breast Pump.
| Device ID | K043098 |
| 510k Number | K043098 |
| Device Name: | GERBER DOUBLE ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | GERBER PRODUCTS CO. 445 STATE ST. Fremont, MI 49413 |
| Contact | Ranga Ranganathan |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-11-09 |
| Decision Date | 2004-12-15 |
| Summary: | summary |