Tandry CMF Plate System

Plate, Bone

Microware Precision Co., Ltd.

The following data is part of a premarket notification filed by Microware Precision Co., Ltd. with the FDA for Tandry Cmf Plate System.

Pre-market Notification Details

Device IDK220360
510k NumberK220360
Device Name:Tandry CMF Plate System
ClassificationPlate, Bone
Applicant Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung,  TW 40763
ContactHarrison Du
CorrespondentHarrison Du
Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung,  TW 40763
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-08
Decision Date2022-11-10

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