The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c. 125 Negative Pressure Wound Therapy Unit.
| Device ID | K111280 |
| 510k Number | K111280 |
| Device Name: | V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh KCI USA, INC. 6203 FARINON DR. 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 | 2011-05-06 |
| Decision Date | 2011-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554003187 | K111280 | 000 |