4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS

Arthroscope

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for 4mm & 5mm Full Radius Blade Plus, 4mm & 5mm Barrel Bur Plus/4mm Barrel Tornado Bur Plus, 4mm & 5mm Aggressive Blade Plus.

Pre-market Notification Details

Device IDK131191
510k NumberK131191
Device Name:4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS
ClassificationArthroscope
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactSusan Kagan
CorrespondentSusan Kagan
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-26
Decision Date2013-07-22
Summary:summary

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