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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 K191460
Device Name PWD Platform Wound Dressing 3” x 5” Oblong
Applicant
Applied Tissue Technologies, LLC
99 Derby St., Suite 700
Hingham,  MA  02043
Applicant Contact Michael Broomhead
Correspondent
Lakeshore Medical Device Consulting, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact Michele Lucey
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/03/2019
Decision Date 07/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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