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 K202217
Device Name Kendall NPWT Incision Management Device
Applicant
Cardinal Health
3651 Birchwood Drive
Waukegan,  IL  60085
Applicant Contact Christine Kuntz-Nassif
Correspondent
Patient Recovery, Cardinal Health
777 West Street
Mansfield,  MA  02048
Correspondent Contact Jillian Connery
Regulation Number878.4780
Classification Product Code
OMP  
Date Received08/06/2020
Decision Date 06/04/2021
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
-
-