FDA 510(k) Application Details - K091579

Device Classification Name Perimeter, Automatic, Ac-Powered

  More FDA Info for this Device
510(K) Number K091579
Device Name Perimeter, Automatic, Ac-Powered
Applicant NOTAL VISION LTD.
733 BOLSANA DRIVE
LAGUNA BEACH, CA 92651 US
Other 510(k) Applications for this Company
Contact Judy Gordon
Other 510(k) Applications for this Contact
Regulation Number 886.1605

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

  More FDA Info for this Product Code
Date Received 06/02/2009
Decision Date 12/23/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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