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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 K181465
Device Name SpaceOAR System
Applicant
Augmenix, Inc.
201 Burlington Rd.
Bedford,  MA  01730
Applicant Contact Marcus Garcia
Correspondent
Augmenix, Inc.
201 Burlington Rd.
Bedford,  MA  01730
Correspondent Contact Marcus Garcia
Regulation Number892.5725
Classification Product Code
OVB  
Date Received06/04/2018
Decision Date 06/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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