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 Lavage, Jet
510(k) Number K143115
Device Name The VersaJet II Hydrosurgery System
Applicant
Smith & Nephew, Inc.
970 Lake Carillon Dr.
Suite 110
St Petersburg,  FL  33716
Applicant Contact Laura Reynolds
Correspondent
Smith & Nephew, Inc.
970 Lake Carillon Dr.
Suite 110
St Petersburg,  FL  33716
Correspondent Contact Laura Reynolds
Regulation Number880.5475
Classification Product Code
FQH  
Date Received10/30/2014
Decision Date 07/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-