ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR

Arthroscope

ORTHOCONCEPT, INC.

The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Arthroscopy Disp. & Reusable Shaver Blades, Rechar.

Pre-market Notification Details

Device IDK896196
510k NumberK896196
Device Name:ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR
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 Received1989-10-25
Decision Date1989-12-01

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