PERCSCOPE MODEL 2600

Arthroscope

CLARUS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Percscope Model 2600.

Pre-market Notification Details

Device IDK974579
510k NumberK974579
Device Name:PERCSCOPE MODEL 2600
ClassificationArthroscope
Applicant CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
ContactDale Sappenfield
CorrespondentDale Sappenfield
CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-08
Decision Date1998-02-18
Summary:summary

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