MICROSURGICAL INSTRUMENTS

Arthroscope

DANEK MEDICAL, INC.

The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Microsurgical Instruments.

Pre-market Notification Details

Device IDK911300
510k NumberK911300
Device Name:MICROSURGICAL INSTRUMENTS
ClassificationArthroscope
Applicant DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis,  TN  38131
ContactRichard W Treharne
CorrespondentRichard W Treharne
DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis,  TN  38131
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-25
Decision Date1991-04-05

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