The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Cannulae.
Device ID | K102566 |
510k Number | K102566 |
Device Name: | OWL CANNULAE |
Classification | Probe, Radiofrequency Lesion |
Applicant | DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario, CA L3r 3k8 |
Contact | George Darmos |
Correspondent | George Darmos DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario, CA L3r 3k8 |
Product Code | GXI |
CFR Regulation Number | 882.4725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-07 |
Decision Date | 2011-06-03 |
Summary: | summary |