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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K132936
Device Name NOVOPORE DRESSING
Applicant
Polynovo Biomaterials Pty, Ltd.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Applicant Contact Carrie Hetrick
Correspondent
Polynovo Biomaterials Pty, Ltd.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Carrie Hetrick
Regulation Number878.4780
Classification Product Code
OMP  
Date Received09/18/2013
Decision Date 03/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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