The following data is part of a premarket notification filed by Talley Group Ltd. with the FDA for Venturi Gauze Wound Care Sets With Portal Drain.
| Device ID | K151263 |
| 510k Number | K151263 |
| Device Name: | Venturi Gauze Wound Care Sets With Portal Drain |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | TALLEY GROUP LTD. PREMIER WAY, ABBEY PARK INDUSTRIAL ESTATE Romsey, GB So51 9dq |
| Contact | Robert Macdonald |
| Correspondent | Phil Bromley SGR CONSULTING SERVICES 8 HOLLINGWORTH COURT, TURKEY MILL, ASHFORD ROAD Maidstone, GB Me14 5pp |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-13 |
| Decision Date | 2016-02-19 |
| Summary: | summary |