The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress.
| Device ID | K133276 |
| 510k Number | K133276 |
| Device Name: | V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
| Contact | Melanie Avila |
| Correspondent | Melanie Avila KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-24 |
| Decision Date | 2013-11-19 |
| Summary: | summary |