SpaceOAR System

Hydrogel Spacer

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spaceoar System.

Pre-market Notification Details

Device IDK202224
510k NumberK202224
Device Name:SpaceOAR System
ClassificationHydrogel Spacer
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactJeanne Otoole
CorrespondentJeanne Otoole
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodeOVB  
CFR Regulation Number892.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-07
Decision Date2020-08-28

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