Si-Mochi

Filler, Bone Void, Calcium Compound

Biostone Ltd

The following data is part of a premarket notification filed by Biostone Ltd with the FDA for Si-mochi.

Pre-market Notification Details

Device IDK202639
510k NumberK202639
Device Name:Si-Mochi
ClassificationFiller, Bone Void, Calcium Compound
Applicant Biostone Ltd BioCity, Pennyfoot Street Nottingham,  GB Ng1 1gf
ContactWei-jen Lo
CorrespondentWei-jen Lo
Biostone Ltd BioCity, Pennyfoot Street Nottingham,  GB Ng1 1gf
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2021-04-21

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