The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medelas Breast Pump.
| Device ID | K950750 |
| 510k Number | K950750 |
| Device Name: | MEDELAS BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA, INC. 4610 PRIME PKWY. P.O. BOX 660 Mchenry, IL 60050 -7005 |
| Contact | Stephen D Smith |
| Correspondent | Stephen D Smith MEDELA, INC. 4610 PRIME PKWY. P.O. BOX 660 Mchenry, IL 60050 -7005 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-17 |
| Decision Date | 1995-10-16 |