BellaFuse

Filler, Bone Void, Calcium Compound

Hans Biomed Corp.

The following data is part of a premarket notification filed by Hans Biomed Corp. with the FDA for Bellafuse.

Pre-market Notification Details

Device IDK151271
510k NumberK151271
Device Name:BellaFuse
ClassificationFiller, Bone Void, Calcium Compound
Applicant Hans Biomed Corp. 64,Yuseong-Daero 1628Beon-Gil, Yuseong-Gu Daejeon,  KR 305-811
ContactLucy Choi
CorrespondentPatsy J Trisler
Trisler Consulting 5600 Wisconsin Ave, #509 Chevy Chase,  MD  20815
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-13
Decision Date2016-03-11
Summary:summary

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