Laparoscope Lens Shield Device (LENS)

Laparoscope, General & Plastic Surgery

Medeon Biodesign, Inc

The following data is part of a premarket notification filed by Medeon Biodesign, Inc with the FDA for Laparoscope Lens Shield Device (lens).

Pre-market Notification Details

Device IDK192891
501k NumberK192891
Device Name:Laparoscope Lens Shield Device (LENS)
ClassificationLaparoscope, General & Plastic Surgery
Applicant Medeon Biodesign, Inc 7F, 116 Hougang St., Taipei,  TW 11170
ContactTsung-yu Hsieh
CorrespondentTsung-yu Hsieh
Medeon Biodesign, Inc 7F, 116 Hougang St., Taipei,  TW 11170
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-10
Decision Date2019-11-07

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