The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for V.a.c. Ulta Negative Pressure Wound Therapy System (v.a.c. Ulta Therapy System) Model V.a.c. Ulta Therapy Unit Model U.
| Device ID | K100657 |
| 510k Number | K100657 |
| Device Name: | V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-08 |
| Decision Date | 2010-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554001909 | K100657 | 000 |
| 00849554001374 | K100657 | 000 |
| 00849554001312 | K100657 | 000 |
| 00849554001305 | K100657 | 000 |
| 00849554001299 | K100657 | 000 |
| 00849554001244 | K100657 | 000 |
| 00849554000636 | K100657 | 000 |