FIBERGRAFT BG MORSELS

Filler, Bone Void, Calcium Compound

PROSIDYAN, INC

The following data is part of a premarket notification filed by Prosidyan, Inc with the FDA for Fibergraft Bg Morsels.

Pre-market Notification Details

Device IDK141956
510k NumberK141956
Device Name:FIBERGRAFT BG MORSELS
ClassificationFiller, Bone Void, Calcium Compound
Applicant PROSIDYAN, INC 1835 MARKET STREET, 29TH FLOOR Philadelpiha,  PA  19103
ContactJanice M Hogan
CorrespondentJanice M Hogan
PROSIDYAN, INC 1835 MARKET STREET, 29TH FLOOR Philadelpiha,  PA  19103
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-18
Decision Date2014-08-13
Summary:summary

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