The following data is part of a premarket notification filed by Mapa Gmbh with the FDA for E-basic Single Breast Pump.
| Device ID | K101157 |
| 510k Number | K101157 |
| Device Name: | E-BASIC SINGLE BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | MAPA GMBH 2081 LONGDEN CIRCLE Los Altos, CA 94024 |
| Contact | Sheila W Pickering |
| Correspondent | Sheila W Pickering MAPA GMBH 2081 LONGDEN CIRCLE Los Altos, CA 94024 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-26 |
| Decision Date | 2010-09-17 |
| Summary: | summary |