IRIS Thermocoagulator And Digital Colposcope

Electrocautery, Gynecologic (and Accessories)

Liger Medical, LLC

The following data is part of a premarket notification filed by Liger Medical, Llc with the FDA for Iris Thermocoagulator And Digital Colposcope.

Pre-market Notification Details

Device IDK202915
510k NumberK202915
Device Name:IRIS Thermocoagulator And Digital Colposcope
ClassificationElectrocautery, Gynecologic (and Accessories)
Applicant Liger Medical, LLC 3300 North Running Creek Way, Building G, Suite G20 Lehi,  UT  84043
ContactWm. Dean Wallace
CorrespondentWm. Dean Wallace
Liger Medical, LLC 3300 North Running Creek Way, Building G, Suite G20 Lehi,  UT  84043
Product CodeHGI  
CFR Regulation Number884.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-04-23

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