FDA 510(k) Application Details - K003896

Device Classification Name Electrode, Cutaneous

  More FDA Info for this Device
510(K) Number K003896
Device Name Electrode, Cutaneous
Applicant BEXLEY TRADING, INC.
1105 BUCKBRUSH DR.
FOLSOM, CA 95630 US
Other 510(k) Applications for this Company
Contact MICHAEL ZMUDA
Other 510(k) Applications for this Contact
Regulation Number 882.1320

  More FDA Info for this Regulation Number
Classification Product Code GXY
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/18/2000
Decision Date 04/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact