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 Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K162421
Device Name IntelliCartTM System
Applicant
Dornoch Medical Systems
200 N. W. Pkwy.
Riverside,  MO  64150
Applicant Contact LARRY SMITH
Correspondent
Dornoch Medical Systems
200 N. W. Pkwy.
Riverside,  MO  64150
Correspondent Contact MICHAEL WOLFORD
Regulation Number878.4780
Classification Product Code
JCX  
Date Received08/30/2016
Decision Date 12/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-