The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Invia Wound Therapy.
| Device ID | K080357 |
| 510k Number | K080357 |
| Device Name: | MEDELA INVIA WOUND THERAPY |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Contact | Bruno Gretler |
| Correspondent | Bruno Gretler MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2008-07-24 |
| Summary: | summary |