LARS AC Band Device

Washer, Bolt Nut

Corin USA

The following data is part of a premarket notification filed by Corin Usa with the FDA for Lars Ac Band Device.

Pre-market Notification Details

Device IDK190143
501k NumberK190143
Device Name:LARS AC Band Device
ClassificationWasher, Bolt Nut
Applicant Corin USA 12750 Citrus Park Lane, Suite 120 Tampa,  FL  33625
ContactLucinda Gerber
CorrespondentLucinda Gerber
Corin USA 12750 Citrus Park Lane, Suite 120 Tampa,  FL  33625
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-29
Decision Date2019-11-04

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