The following data is part of a premarket notification filed by Medela Ag with the FDA for Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large.
| Device ID | K151261 |
| 510k Number | K151261 |
| Device Name: | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Medela AG Laettichstrasse 4 Baar Zug, CH Ch-6341 |
| Contact | Orlando Antunes |
| Correspondent | E.j. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-12 |
| Decision Date | 2015-10-07 |
| Summary: | summary |