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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbable Synthetic Wound Dressing
510(k) Number K170213
Device Name SupraSDRM Biodegradable Matrix Wound Dressing
Applicant
Polymedics Innovations, GmbH
Heerweg 15d
Denkendorf,  DE 73770
Applicant Contact Kenneth K. Kleinhenz
Correspondent
Polymedics Innovations, GmbH
Heerweg 15d
Denkendorf,  DE 73770
Correspondent Contact Kenneth K. Kleinhenz
Classification Product Code
QSZ  
Date Received01/24/2017
Decision Date 06/28/2017
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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