The following data is part of a premarket notification filed by Minta Medical Limited with the FDA for Minta Ryan Rf Thermocouple Electrode (ryan-50, 100, 150 And 200), Minta Intermediate Cable (ryan-c, -r, -b).
Device ID | K090608 |
510k Number | K090608 |
Device Name: | MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) |
Classification | Probe, Radiofrequency Lesion |
Applicant | MINTA MEDICAL LIMITED CADDICK ROAD Knowsley Merseyside, GB L34 9hp |
Contact | Andrew Edwards |
Correspondent | Andrew Edwards MINTA MEDICAL LIMITED CADDICK ROAD Knowsley Merseyside, GB L34 9hp |
Product Code | GXI |
CFR Regulation Number | 882.4725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-06 |
Decision Date | 2010-06-14 |
Summary: | summary |