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 K143016
Device Name Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
Applicant
CARDINAL HEALTH
1500 S Waukegan Rd
Waukegan,  IL  60085
Applicant Contact Tatyana Bogdan
Correspondent
NAVIGANT CONSULTING, INC.
9001 WESLEYAN ROAD, SUITE 200
INDIANAPOLIS,  IN  46268
Correspondent Contact ALLISON SCOTT
Regulation Number878.4780
Classification Product Code
OMP  
Date Received10/20/2014
Decision Date 04/20/2015
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
Recalls CDRH Recalls
-
-