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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hydrogel spacer
510(k) Number K202224
Device Name SpaceOAR System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Jeanne OToole
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Jeanne OToole
Regulation Number892.5725
Classification Product Code
OVB  
Date Received08/07/2020
Decision Date 08/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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