INCLUSICE II(TM) ENDOSCOPE

Arthroscope

SOFAMOR DANEK USA,INC.

The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Inclusice Ii(tm) Endoscope.

Pre-market Notification Details

Device IDK946087
510k NumberK946087
Device Name:INCLUSICE II(TM) ENDOSCOPE
ClassificationArthroscope
Applicant SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-13
Decision Date1995-11-21

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