DSM Biomedical Calcium Phosphate Cement With Microspheres

Filler, Bone Void, Calcium Compound

Kensey Nash Corporation Dba DSM Biomedical

The following data is part of a premarket notification filed by Kensey Nash Corporation Dba Dsm Biomedical with the FDA for Dsm Biomedical Calcium Phosphate Cement With Microspheres.

Pre-market Notification Details

Device IDK173572
510k NumberK173572
Device Name:DSM Biomedical Calcium Phosphate Cement With Microspheres
ClassificationFiller, Bone Void, Calcium Compound
Applicant Kensey Nash Corporation Dba DSM Biomedical 735 Pennsylvania Drive Exton,  PA  19431
ContactSusan Pileggi
CorrespondentSusan Pileggi
Kensey Nash Corporation Dba DSM Biomedical 735 Pennsylvania Drive Exton,  PA  19431
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-20
Decision Date2018-05-09
Summary:summary

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