The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for V.a.c. Therapy System.
| Device ID | K062227 |
| 510k Number | K062227 |
| Device Name: | V.A.C. THERAPY SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. (KINETIC CONCEPTS, INC.) 8023 VANTAGE DRIVE San Antonio, TX 78230 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh KCI USA, INC. (KINETIC CONCEPTS, INC.) 8023 VANTAGE DRIVE San Antonio, TX 78230 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2006-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00878237001141 | K062227 | 000 |
| 00849554006881 | K062227 | 000 |
| 00849554006874 | K062227 | 000 |