Endiscope, Endiscope Cervical

Arthroscope

Elliquence, LLC

The following data is part of a premarket notification filed by Elliquence, Llc with the FDA for Endiscope, Endiscope Cervical.

Pre-market Notification Details

Device IDK180766
510k NumberK180766
Device Name:Endiscope, Endiscope Cervical
ClassificationArthroscope
Applicant Elliquence, LLC 2455 Grand Avenue Baldwin,  NY  11510
ContactPaul D. Buhrke
CorrespondentPaul D. Buhrke
Elliquence, LLC 2455 Grand Avenue Baldwin,  NY  11510
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-23
Decision Date2018-06-11
Summary:summary

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