FDA 510(k) Application Details - K991522

Device Classification Name Electrode, Depth

  More FDA Info for this Device
510(K) Number K991522
Device Name Electrode, Depth
Applicant FHC, INC.
9 MAIN ST.
BOWDOINHAM, ME 04008 US
Other 510(k) Applications for this Company
Contact FREDERICK HAER
Other 510(k) Applications for this Contact
Regulation Number 882.1330

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

  More FDA Info for this Product Code
Date Received 05/03/1999
Decision Date 08/04/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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