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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 K151240
Device Name extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
Applicant
Devon Medical Products
1100 First Ave., Suite 202
King Of Prussia,  PA  19406
Applicant Contact JOHN SIEGEL
Correspondent
Devon Medical Products
1100 First Ave., Suite 202
King Of Prussia,  PA  19406
Correspondent Contact STEVE XU
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/11/2015
Decision Date 06/09/2015
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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