The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c. Therapy Systems - Info V.a.c. Therapy Uniy, Model M6257766.
| Device ID | K063740 |
| 510k Number | K063740 |
| Device Name: | V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 8023 VANTAGE DR. San Antonio, TX 78230 -4726 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh KCI USA, INC. 8023 VANTAGE DR. San Antonio, TX 78230 -4726 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-18 |
| Decision Date | 2007-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00878237008195 | K063740 | 000 |
| 00878237000915 | K063740 | 000 |
| 00878237000892 | K063740 | 000 |
| 00849554002081 | K063740 | 000 |
| 00849554002074 | K063740 | 000 |
| 00849554006799 | K063740 | 000 |