The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medela's Foot Pump.
| Device ID | K952034 |
| 510k Number | K952034 |
| Device Name: | MEDELA'S FOOT PUMP |
| Classification | Pump, Breast, Non-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 | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-09-12 |