ABCcolla Bone Matrix

Filler, Bone Void, Calcium Compound

ACRO Biomedical Co., Ltd.

The following data is part of a premarket notification filed by Acro Biomedical Co., Ltd. with the FDA for Abccolla Bone Matrix.

Pre-market Notification Details

Device IDK212156
510k NumberK212156
Device Name:ABCcolla Bone Matrix
ClassificationFiller, Bone Void, Calcium Compound
Applicant ACRO Biomedical Co., Ltd. 3rd Fl., No.57, Luke 2nd Rd., Lujhu Dist. Kaohsiung,  TW 82151
ContactDar-jen Hsieh
CorrespondentDar-jen Hsieh
ACRO Biomedical Co., Ltd. 3rd Fl., No.57, Luke 2nd Rd., Lujhu Dist. Kaohsiung,  TW 82151
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-12
Decision Date2021-10-08

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