The following data is part of a premarket notification filed by Medela, Ag with the FDA for Invia Foam Dressing Kits With Fitpad, Invia Foam Dressing Kits With Fitpad, Invia Gauze Dressing Kits With Fitpad, Invia Fitpad, Invia Transparent Film.
| Device ID | K170088 |
| 510k Number | K170088 |
| Device Name: | Invia Foam Dressing Kits With FitPad, Invia Foam Dressing Kits With FitPad, Invia Gauze Dressing Kits With FitPad, Invia FitPad, Invia Transparent Film |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MEDELA, AG Lattichstrasse 4b Baar, CH 6341 |
| Contact | Markus Butler |
| Correspondent | Julian Thorns PROSYSTEM AG Beim Strohhause 17 Hamburg, DE 20097 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-10 |
| Decision Date | 2017-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367050241 | K170088 | 000 |
| 07612367050180 | K170088 | 000 |
| 07612367050166 | K170088 | 000 |
| 07612367050135 | K170088 | 000 |
| 07612367050111 | K170088 | 000 |
| 07612367050081 | K170088 | 000 |
| 07612367050029 | K170088 | 000 |
| 07612367049610 | K170088 | 000 |