The following data is part of a premarket notification filed by Talley Medical with the FDA for Venturi Npwt V. Ii Advanced Vacuum System.
| Device ID | K090258 |
| 510k Number | K090258 |
| Device Name: | VENTURI NPWT V. II ADVANCED VACUUM SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | TALLEY MEDICAL 1070 E. WIELAND RD. Lansing, MI 48906 |
| Contact | Jack Van Dyke |
| Correspondent | Jack Van Dyke TALLEY MEDICAL 1070 E. WIELAND RD. Lansing, MI 48906 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-02 |
| Decision Date | 2009-08-25 |
| Summary: | summary |