Applied Medical Laparoscopic Linear Cutter

Staple, Implantable

Applied Medical Resources Corporation

The following data is part of a premarket notification filed by Applied Medical Resources Corporation with the FDA for Applied Medical Laparoscopic Linear Cutter.

Pre-market Notification Details

Device IDK190331
501k NumberK190331
Device Name:Applied Medical Laparoscopic Linear Cutter
ClassificationStaple, Implantable
Applicant Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
ContactAditi Iyengar
CorrespondentAditi Iyengar
Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita,  CA  92688
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-14
Decision Date2019-11-22

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