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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 K161432
Device Name MyNeWT Negative Pressure Wound Therapy System
Applicant
Stortford Medical, LLC
295 Princeton Hightstown Rd., Unit 321
West Windsor,  NJ  08550
Applicant Contact Chris Daughtery
Correspondent
Stortford Medical, LLC
295 Princeton Hightstown Rd., Unit 321
West Windsor,  NJ  08550
Correspondent Contact Chris Daughtery
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/24/2016
Decision Date 02/08/2017
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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