The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Prevena Incision Management System.
Device ID | K100821 |
510k Number | K100821 |
Device Name: | PREVENA INCISION MANAGEMENT SYSTEM |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
Contact | Margaret Marsh |
Correspondent | Margaret Marsh KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-23 |
Decision Date | 2010-06-11 |
Summary: | summary |