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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 K111949
Device Name AC WOUND TREATMENT SYSTEM
Applicant
Nanovibronix, Inc.
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
Nanovibronix, Inc.
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/08/2011
Decision Date 06/29/2012
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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