The following data is part of a premarket notification filed by Talley Medical with the FDA for Venturi Negative Pressure Wound Therapy System.
| Device ID | K080897 |
| 510k Number | K080897 |
| Device Name: | VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | TALLEY MEDICAL 4740 JADESTONE DR. Williamston, MI 48895 |
| Contact | Jack Van Dyke |
| Correspondent | Jack Van Dyke TALLEY MEDICAL 4740 JADESTONE DR. Williamston, MI 48895 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-07-15 |
| Summary: | summary |