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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
510(k) Number K213552
Device Name PuraStat-RM
Applicant
3-D Matrix, Inc.
1234 Chestnut St., Suite 205
Newton,  MA  02464
Applicant Contact Lisa Spirio
Correspondent
Streamline Regulatory
3502 Dundee Dr.Way
Chevy Chase,  MD  20815
Correspondent Contact Stephen P Rhodes
Classification Product Code
PHN  
Date Received11/08/2021
Decision Date 04/01/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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