OWL URF-3AP

Generator, Lesion, Radiofrequency

DIROS TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Urf-3ap.

Pre-market Notification Details

Device IDK062758
510k NumberK062758
Device Name:OWL URF-3AP
ClassificationGenerator, Lesion, Radiofrequency
Applicant DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario,  CA L3r 3k8
ContactGeorge Darmos
CorrespondentGeorge Darmos
DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario,  CA L3r 3k8
Product CodeGXD  
CFR Regulation Number882.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-15
Decision Date2006-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00825114003064 K062758 000

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