The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Universal Rf System Urf-3ap (ml).
Device ID | K093185 |
510k Number | K093185 |
Device Name: | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-09 |
Decision Date | 2010-01-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00825114000421 | K093185 | 000 |
00825114000025 | K093185 | 000 |
00825114000018 | K093185 | 000 |