Flap Fixator, Burr Hole Cover

Cover, Burr Hole

Ossaware Biotech Co., Ltd.

The following data is part of a premarket notification filed by Ossaware Biotech Co., Ltd. with the FDA for Flap Fixator, Burr Hole Cover.

Pre-market Notification Details

Device IDK192310
510k NumberK192310
Device Name:Flap Fixator, Burr Hole Cover
ClassificationCover, Burr Hole
Applicant Ossaware Biotech Co., Ltd. No. 51, Xinggong Rd. Shenkang Hsiang,  TW 50971
ContactMeng Feng Huang
CorrespondentMeng Feng Huang
Ossaware Biotech Co., Ltd. No. 51, Xinggong Rd. Shenkang Hsiang,  TW 50971
Product CodeGXR  
CFR Regulation Number882.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-26
Decision Date2020-06-03

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