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 Stimulator, Nerve
510(k) Number K014165
Device Name STIMULUS - DISSECTION INSTRUMENTS
Applicant
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Applicant Contact MARTIN D SARGENT
Correspondent
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216
Correspondent Contact MARTIN D SARGENT
Regulation Number874.1820
Classification Product Code
ETN  
Date Received12/19/2001
Decision Date 01/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-