Device Classification Name |
Negative Pressure Wound Therapy Powered Suction Pump
|
510(k) 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 |
Applicant |
MEDELA, AG |
Lattichstrasse 4b |
Baar,
CH
6341
|
|
Applicant Contact |
Markus Butler |
Correspondent |
PROSYSTEM AG |
Beim Strohhause 17 |
HAMBURG,
DE
20097
|
|
Correspondent Contact |
Julian Thorns |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 01/10/2017 |
Decision Date | 04/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|