HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM

Electrosurgical, Cutting & Coagulation & Accessories

HET SYSTEMS, LLC

The following data is part of a premarket notification filed by Het Systems, Llc with the FDA for Het Systems, Llc, Het Bipolar Ligator System.

Pre-market Notification Details

Device IDK140422
510k NumberK140422
Device Name:HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant HET SYSTEMS, LLC 200 MIDDLESEX TURNPIKE SUITE 304 Iselin,  NJ  08830
ContactHoward L Schrayer
CorrespondentHoward L Schrayer
HET SYSTEMS, LLC 200 MIDDLESEX TURNPIKE SUITE 304 Iselin,  NJ  08830
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-18
Decision Date2014-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521511170 K140422 000
10884521511149 K140422 000
20884521511139 K140422 000
10884521539792 K140422 000
10884521511156 K140422 000

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