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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K193085
Device Name PuraDERM Gel
Applicant
3-D Matrix, Inc.
250 First Ave., Suite 205
Needham,  MA  02494
Applicant Contact Lisa Spirio
Correspondent
Streamline Regulatory
3502 Dundee Dr.way
Chevy Chase,  MD  20815
Correspondent Contact Stephen P. Rhodes
Classification Product Code
FRO  
Date Received11/05/2019
Decision Date 05/11/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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