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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060548020095 K202639 000
05060548020132 K202639 000
05060548020149 K202639 000
05060548020156 K202639 000
05060548020163 K202639 000
05060548020194 K202639 000
05060548020200 K202639 000
05060548020002 K202639 000
05060548020019 K202639 000
05060548020026 K202639 000
05060548020033 K202639 000
05060548020088 K202639 000
05060548020101 K202639 000
05060548020125 K202639 000

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