The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Vario Suction Pumps.
| Device ID | K061435 |
| 510k Number | K061435 |
| Device Name: | MEDELA VARIO SUCTION PUMPS |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Contact | Werner Frei |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-24 |
| Decision Date | 2006-06-08 |
| Summary: | summary |