DANEKSCOPE OPTI-PROBE

Arthroscope

DANEK MEDICAL, INC.

The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Danekscope Opti-probe.

Pre-market Notification Details

Device IDK943676
510k NumberK943676
Device Name:DANEKSCOPE OPTI-PROBE
ClassificationArthroscope
Applicant DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis,  TN  38132
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-26
Decision Date1994-11-21

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