ECT Cotton Bite Block- Size Large, ECT Cotton Bite Block -size Medium

Block, Bite

MECTA Corporation

The following data is part of a premarket notification filed by Mecta Corporation with the FDA for Ect Cotton Bite Block- Size Large, Ect Cotton Bite Block -size Medium.

Pre-market Notification Details

Device IDK201309
510k NumberK201309
Device Name:ECT Cotton Bite Block- Size Large, ECT Cotton Bite Block -size Medium
ClassificationBlock, Bite
Applicant MECTA Corporation 19799 SW 95th Avenue Suite B Tualatin,  OR  97062
ContactAdrian Kettering
CorrespondentAdrian Kettering
MECTA Corporation 19799 SW 95th Avenue Suite B Tualatin,  OR  97062
Product CodeJXL  
CFR Regulation Number882.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-15
Decision Date2021-06-04

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