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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name polymer, ear, nose and throat, synthetic, absorbable
510(k) Number K183015
Device Name PuraSinus
3-D Matrix, Inc.
250 First Ave., Suite 205
Needham,  MA  02494
Applicant Contact Lisa Spirio
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Stephen P. Rhodes
Regulation Number874.3620
Classification Product Code
Date Received10/31/2018
Decision Date 04/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls