BIOSORB RESORBABLE VOID FILLER

Filler, Bone Void, Calcium Compound

SCIENCES ET BIO MATERIAUX (SBM)

The following data is part of a premarket notification filed by Sciences Et Bio Materiaux (sbm) with the FDA for Biosorb Resorbable Void Filler.

Pre-market Notification Details

Device IDK021963
510k NumberK021963
Device Name:BIOSORB RESORBABLE VOID FILLER
ClassificationFiller, Bone Void, Calcium Compound
Applicant SCIENCES ET BIO MATERIAUX (SBM) ZI DU MONGE Lordes,  FR F 65100
ContactDenis Clement
CorrespondentDenis Clement
SCIENCES ET BIO MATERIAUX (SBM) ZI DU MONGE Lordes,  FR F 65100
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-14
Decision Date2003-01-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03760154007009 K021963 000
03760154000192 K021963 000
03760154000208 K021963 000
03760154000215 K021963 000
03760154000246 K021963 000
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03760154000130 K021963 000
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03760154004275 K021963 000
03760154004282 K021963 000
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03760154004824 K021963 000
03760154004831 K021963 000
03760154004237 K021963 000
03760154004220 K021963 000
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03760154000406 K021963 000
03760154000420 K021963 000
03760154000451 K021963 000
03760154000475 K021963 000
03760154000666 K021963 000
03760154000697 K021963 000
03760154000680 K021963 000

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