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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K031675
Device Name SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
Applicant
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact KAREN PROVENCHER
Correspondent
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact KAREN PROVENCHER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/30/2003
Decision Date 06/20/2003
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
Recalls CDRH Recalls
-
-