MICROWARE BONE PLATES AND BONE SCREWS

Plate, Fixation, Bone

MICROWARE PRECISION CO., LTD.

The following data is part of a premarket notification filed by Microware Precision Co., Ltd. with the FDA for Microware Bone Plates And Bone Screws.

Pre-market Notification Details

Device IDK072562
510k NumberK072562
Device Name:MICROWARE BONE PLATES AND BONE SCREWS
ClassificationPlate, Fixation, Bone
Applicant MICROWARE PRECISION CO., LTD. NO. 12 KEYUAN 2ND RD. SITUN DISTRICT Taichung City,  TW 40763
ContactHarrison Du
CorrespondentHarrison Du
MICROWARE PRECISION CO., LTD. NO. 12 KEYUAN 2ND RD. SITUN DISTRICT Taichung City,  TW 40763
Product CodeHRS  
Subsequent Product CodeHWC
Subsequent Product CodeKTT
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-11
Decision Date2008-12-04
Summary:summary

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