The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Modification To: V.a.c. Granufoam Silver Protection Dressing.
| Device ID | K053627 |
| 510k Number | K053627 |
| Device Name: | MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 8023 VANTAGE DR. San Antonio, TX 78230 -4726 |
| Contact | Christy H Oviatt |
| Correspondent | Christy H Oviatt 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 | Yes |
| Date Received | 2005-12-29 |
| Decision Date | 2006-02-06 |
| Summary: | summary |