The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c. Freedom Canister, Model M6275421; V.a.c. Ats Canister, Models K6275422, M6275423.
Device ID | K063590 |
510k Number | K063590 |
Device Name: | V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | KCI USA, INC. 8023 VANTAGE DR. San Antonio, TX 78230 -4726 |
Contact | Christy Hubbard Oviatt |
Correspondent | Christy Hubbard Oviatt KCI USA, INC. 8023 VANTAGE DR. San Antonio, TX 78230 -4726 |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-01 |
Decision Date | 2007-01-25 |
Summary: | summary |