ALTAPORE SHAPE

Filler, Bone Void, Calcium Compound

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Altapore Shape.

Pre-market Notification Details

Device IDK200640
510k NumberK200640
Device Name:ALTAPORE SHAPE
ClassificationFiller, Bone Void, Calcium Compound
Applicant Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake,  IL  60073
ContactPhillip Romei
CorrespondentPhillip Romei
Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake,  IL  60073
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-11
Decision Date2020-05-08

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