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 |