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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 K140634
Device Name extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit
Applicant
Devon Medical, Inc.
1100 First Avenue, Suite 202
King of Prussia,  PA  19406
Applicant Contact Steve XU
Correspondent
Devon Medical, Inc.
1100 First Avenue, Suite 202
King of Prussia,  PA  19406
Correspondent Contact Steve XU
Regulation Number878.4780
Classification Product Code
OMP  
Date Received03/12/2014
Decision Date 09/19/2014
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
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