The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Urf-3ap.
Device ID | K062758 |
510k Number | K062758 |
Device Name: | OWL URF-3AP |
Classification | Generator, Lesion, Radiofrequency |
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 | GXD |
CFR Regulation Number | 882.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-15 |
Decision Date | 2006-09-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00825114003064 | K062758 | 000 |