Amputee Garment For Use With Lympha Press Optimal Plus

Sleeve, Limb, Compressible

Mego Afek AC Ltd.

The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Amputee Garment For Use With Lympha Press Optimal Plus.

Pre-market Notification Details

Device IDK214053
510k NumberK214053
Device Name:Amputee Garment For Use With Lympha Press Optimal Plus
ClassificationSleeve, Limb, Compressible
Applicant Mego Afek AC Ltd. Kibbuts Afek Kibbuts Afek,  IL 3004200
ContactIlan Sharon
CorrespondentIlan Sharon
Ilan Sharon MD Consultant P.O. Box 4414(A109) Caesarea,  IL 3088900
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-04-14

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