VFS1 Bipolar Electrosurgical Generator

Electrosurgical, Cutting & Coagulation & Accessories

FHC, Inc.

The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Vfs1 Bipolar Electrosurgical Generator.

Pre-market Notification Details

Device IDK200169
510k NumberK200169
Device Name:VFS1 Bipolar Electrosurgical Generator
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant FHC, Inc. 1201 Main Street Bowdoin,  ME  04287
ContactKelly Moeykens
CorrespondentCraig Pagan
C2C Development, LLC 1135 W NASA Blvd, Suite 500 Melbourne,  FL  32901
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-23
Decision Date2020-05-14

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