The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for V.a.c. Granufoam Silver Dressing.
| Device ID | K041642 |
| 510k Number | K041642 |
| Device Name: | V.A.C. GRANUFOAM SILVER DRESSING |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
| Contact | Judith Harbour |
| Correspondent | Judith Harbour KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-06-17 |
| Decision Date | 2005-01-25 |
| Summary: | summary |