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 Media, Electroconductive
510(k) Number K001705
Device Name STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
Applicant
CHESTER LABS, INC.
1900 SECTION RD., SUITE A
CINCINNATI,  OH  45237
Applicant Contact HOLLY SHERWOOD
Correspondent
CHESTER LABS, INC.
1900 SECTION RD., SUITE A
CINCINNATI,  OH  45237
Correspondent Contact HOLLY SHERWOOD
Regulation Number882.1275
Classification Product Code
GYB  
Date Received06/05/2000
Decision Date 06/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-