The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for V.a.c. Veraflo Cleanse Dressing System.
Device ID | K103156 |
510k Number | K103156 |
Device Name: | V.A.C. VERAFLO CLEANSE DRESSING SYSTEM |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | KCI USA, INC. (KINETIC CONCEPTS, INC.) 6203 FARINON DRIVE San Antonio, TX 78249 |
Contact | Margaret Marsh |
Correspondent | Margaret Marsh KCI USA, INC. (KINETIC CONCEPTS, INC.) 6203 FARINON DRIVE San Antonio, TX 78249 |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-26 |
Decision Date | 2011-03-14 |
Summary: | summary |