CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES

Arthroscope

ORTHOCONCEPT, INC.

The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Cordex Shaver, Blades, Recharger And Batteries.

Pre-market Notification Details

Device IDK882469
510k NumberK882469
Device Name:CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES
ClassificationArthroscope
Applicant ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia,  SC  29223
ContactJack Defranco
CorrespondentJack Defranco
ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia,  SC  29223
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-15
Decision Date1988-12-01

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