SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

SURETEK MEDICAL

The following data is part of a premarket notification filed by Suretek Medical with the FDA for Suretek Medical Reprocessed Electrosurgical Electrodes.

Pre-market Notification Details

Device IDK052692
510k NumberK052692
Device Name:SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
ClassificationElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant SURETEK MEDICAL 44 BELLWOOD FARMS Greenville,  SC  29607
ContactMike Sammon
CorrespondentMike Sammon
SURETEK MEDICAL 44 BELLWOOD FARMS Greenville,  SC  29607
Product CodeNUJ  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-28
Decision Date2006-05-10
Summary:summary

NIH GUDID Devices

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