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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oral wound dressing
510(k) Number K210211
Device Name PuraStat-OM
3-D Matrix, Inc.
1234 Chestnut St., Suite 205
Newton,  MA  02464
Applicant Contact Lisa Spirio
Streamline Regulatory
3502 Dundee Driveway
Chevy Chase,  MD  20815
Correspondent Contact Stephen P. Rhodes
Classification Product Code
Subsequent Product Code
Date Received01/27/2021
Decision Date 10/08/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No