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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 K131464
Device Name EXTRICARE NPWT FOOT DRESSING
Applicant
Devon Medical, Inc.
1100 1st Ave.
Suite 200
King Of Prussia,  PA  19406
Applicant Contact RUTH WU
Correspondent
Devon Medical, Inc.
1100 1st Ave.
Suite 200
King Of Prussia,  PA  19406
Correspondent Contact RUTH WU
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/21/2013
Decision Date 08/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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