The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c. Ats Large (1000 Ml) Canister With Gel, Models M6275093/5, M6275093/10.
| Device ID | K063426 |
| 510k Number | K063426 |
| Device Name: | V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 8023 VANTAGE DR. San Antonio, TX 78230 -4726 |
| Contact | Veronique Smith |
| Correspondent | Veronique Smith 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 | 2006-11-13 |
| Decision Date | 2006-12-13 |
| Summary: | summary |