The following data is part of a premarket notification filed by Gerber Products Co. with the FDA for Gerber Natural Comfort Battery Breast Pump.
| Device ID | K942534 |
| 510k Number | K942534 |
| Device Name: | GERBER NATURAL COMFORT BATTERY BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | GERBER PRODUCTS CO. GEN. MDSE. DIV. 728 BOOSTER BLVD. Reedsburg, WI 53959 |
| Contact | Wendy Vandusen |
| Correspondent | Wendy Vandusen GERBER PRODUCTS CO. GEN. MDSE. DIV. 728 BOOSTER BLVD. Reedsburg, WI 53959 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-27 |
| Decision Date | 1995-05-25 |