LOWER EXTREMITY SUPPORT SYSTEM-LESS

Operating Room Accessories Table Tray

WALGEN MEDICAL INNOVENTIONS

The following data is part of a premarket notification filed by Walgen Medical Innoventions with the FDA for Lower Extremity Support System-less.

Pre-market Notification Details

Device IDK810433
510k NumberK810433
Device Name:LOWER EXTREMITY SUPPORT SYSTEM-LESS
ClassificationOperating Room Accessories Table Tray
Applicant WALGEN MEDICAL INNOVENTIONS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFWZ  
CFR Regulation Number878.4950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-19
Decision Date1981-03-13

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