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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 K143058
Device Name PuraDerm Gel
Applicant
3-D Matrix, Inc.
200 W. St. Suite 14
Waltham,  MA  02451
Applicant Contact Lisa Spirio
Correspondent
Tekteam, LLC
2225 E. Bayshore Rd.
Palo Alto,  CA  94303
Correspondent Contact Denise Gottfried
Classification Product Code
FRO  
Date Received10/24/2014
Decision Date 02/13/2015
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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