ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm

Electrosurgical, Cutting & Coagulation & Accessories

Microline Surgical, Inc.

The following data is part of a premarket notification filed by Microline Surgical, Inc. with the FDA for Renew Xr Handpiece, Renew Xr Handpiece 34cm, Renew Xr Handpiece 42cm, Renew Xr Handpiece 25cm, Ratcheted Renew Xr Handpiece 34cm.

Pre-market Notification Details

Device IDK201884
510k NumberK201884
Device Name:ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Microline Surgical, Inc. 50 Dunham Road, Suite 1500 Beverly,  MA  01915
ContactScott Marchand Davis
CorrespondentScott Marchand Davis
Microline Surgical, Inc. 50 Dunham Road, Suite 1500 Beverly,  MA  01915
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-08
Decision Date2020-10-21

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