Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Ave., Suite 202
King Of Prussia,  PA  19406
Applicant Contact Steve XU
Correspondent
Devon Medical, Inc.
1100 First Ave., 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
Predetermined Change
Control Plan Authorized		 No
-
-