SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS

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 Arthroscopic Blades And Burs.

Pre-market Notification Details

Device IDK052695
510k NumberK052695
Device Name:SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
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

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