THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240

Electrosurgical, Cutting & Coagulation & Accessories

THERMEDX, LLC

The following data is part of a premarket notification filed by Thermedx, Llc with the FDA for Thermedx 37-5 Electrocautery Probes, Models Mpj200, Mpj210, Mps220, Mpn230, Bph240.

Pre-market Notification Details

Device IDK102275
510k NumberK102275
Device Name:THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant THERMEDX, LLC 31200 SOLON ROAD UNIT 1 Solon,  OH  44139
ContactJohn R Scoville
CorrespondentJohn R Scoville
THERMEDX, LLC 31200 SOLON ROAD UNIT 1 Solon,  OH  44139
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-11
Decision Date2011-03-25
Summary:summary

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