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 K083375
Device Name RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
Applicant
SMITH & NEPHEW, INC.
970 LAKE CARILLON DR.
SUITE 110
ST. PETERSBURG,  FL  33716
Applicant Contact LAURA KREJCI
Correspondent
SMITH & NEPHEW, INC.
970 LAKE CARILLON DR.
SUITE 110
ST. PETERSBURG,  FL  33716
Correspondent Contact LAURA KREJCI
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/14/2008
Decision Date 02/25/2009
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
Recalls CDRH Recalls
-
-