The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for V. A.c. Veraflo Cleanse Choice Dressing System For Use With The V.a.c. Ulta ....
| Device ID | K160451 |
| 510k Number | K160451 |
| Device Name: | V. A.C. VeraFlo Cleanse Choice Dressing System For Use With The V.A.C. Ulta ... |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. (KINETIC CONCEPTS, INC.) 6203 FARINON DRIVE San Antonio, TX 78249 |
| Contact | Melanie Avila |
| Correspondent | Melanie Avila KCI USA, INC. 6203 FARINON DRIVE 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 | 2016-02-18 |
| Decision Date | 2016-06-20 |
| Summary: | summary |