The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for V.a.c. Granufoam Silver Small Dressing; V.a.c. Granufoam Silver Medium Dressing; V.a.c. Granufoam Silver Large Dressing.
| Device ID | K102956 |
| 510k Number | K102956 |
| Device Name: | V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. (KINETIC CONCEPTS, INC.) 6203 FARINON DRIVE San Antonio, TX 78249 |
| Contact | Shannon Scott |
| Correspondent | Shannon Scott 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-10-04 |
| Decision Date | 2010-12-15 |
| Summary: | summary |