The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Clario Home Care Pump.
| Device ID | K033179 |
| 510k Number | K033179 |
| Device Name: | MEDELA CLARIO HOME CARE PUMP |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDELA AG LAETTICHSTRASSE 4 Ch-6340 Baar, CH |
| Contact | Werner Frei |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-01 |
| Decision Date | 2003-10-15 |
| Summary: | summary |