The following data is part of a premarket notification filed by Medela Ag with the FDA for Invia White Foam Npwt.
| Device ID | K180415 |
| 510k Number | K180415 |
| Device Name: | Invia White Foam NPWT |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Medela AG Laettichstrasse 4b Baar Zug, CH Ch-6341 |
| Contact | Georges Hakim |
| Correspondent | Adrienne Lenz Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, DC 20005 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-15 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367057509 | K180415 | 000 |
| 07612367057493 | K180415 | 000 |