The following data is part of a premarket notification filed by Talley Group Ltd. with the FDA for Venturi Mino Tg600/14.
Device ID | K143004 |
510k Number | K143004 |
Device Name: | VENTURI MiNO TG600/14 |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | TALLEY GROUP LTD. PREMIER WAY, ABBEY PARK INDUSTRIAL ESTATE Romsey, GB So51 9dq |
Contact | Robert William Macdonald |
Correspondent | Robert William Macdonald TALLEY GROUP LTD. PREMIER WAY, ABBEY PARK INDUSTRIAL ESTATE Romsey, GB So51 9dq |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-20 |
Decision Date | 2016-01-05 |
Summary: | summary |