The following data is part of a premarket notification filed by Mapa Gmbh with the FDA for Nuk Expressivetm Double Electric Breast Pump.
| Device ID | K121478 |
| 510k Number | K121478 |
| Device Name: | NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | MAPA GMBH 728 BOOSTER BLVD. Reedsburg, WI 53959 |
| Contact | Mark Wozniak |
| Correspondent | Mark Wozniak MAPA GMBH 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 | 2012-05-18 |
| Decision Date | 2013-04-05 |
| Summary: | summary |