CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000

Retractor

CLARUS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Endoscopic Discectomy System Sitetrac Model 6000.

Pre-market Notification Details

Device IDK980588
510k NumberK980588
Device Name:CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
ClassificationRetractor
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 CodeGAD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-17
Decision Date1998-08-18
Summary:summary

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