The following data is part of a premarket notification filed by Medela, Ag with the FDA for Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters.
| Device ID | K142626 |
| 510k Number | K142626 |
| Device Name: | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MEDELA, AG Lattichstrasse 4b Baar, CH 6341 |
| Contact | Orlando Antunes |
| Correspondent | Adrienne Lenz Pathaway Regulatory Consulting, LLC W324S3649 County Road E Dousman, WI 53118 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2015-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367049580 | K142626 | 000 |
| 07612367049542 | K142626 | 000 |
| 07612367049559 | K142626 | 000 |
| 07612367038904 | K142626 | 000 |
| 07612367016339 | K142626 | 000 |
| 07612367015578 | K142626 | 000 |
| 07612367038782 | K142626 | 000 |
| 07612367038799 | K142626 | 000 |