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 Electrode, Cutaneous
510(k) Number K881872
Device Name TENS ELECTRODE MODEL 238P
Applicant
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Applicant Contact MICHAEL J FINLEY
Correspondent
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Correspondent Contact MICHAEL J FINLEY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/03/1988
Decision Date 06/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-