EP Granules™ BVF

Filler, Bone Void, Calcium Compound

Elute, Inc.

The following data is part of a premarket notification filed by Elute, Inc. with the FDA for Ep Granules™ Bvf.

Pre-market Notification Details

Device IDK180853
510k NumberK180853
Device Name:EP Granules™ BVF
ClassificationFiller, Bone Void, Calcium Compound
Applicant Elute, Inc. 417 Wakara Way Suite 3510 Salt Lake City,  UT  84108
ContactKirk Andriano
CorrespondentAshok Khandkar
Elute, Inc. 417 Wakara Way Suite 3510 Salt Lake City,  UT  84108
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-02
Decision Date2018-08-06
Summary:summary

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