FDA 510(k) Application Details - K121441

Device Classification Name Unit, Cautery, Thermal, Battery-Powered

  More FDA Info for this Device
510(K) Number K121441
Device Name Unit, Cautery, Thermal, Battery-Powered
Applicant BOVIE MEDICAL CORPORATION
5115 Ulmerton Road
--
Clearwater, FL 33760-0000 US
Other 510(k) Applications for this Company
Contact RICHARD A KOZLOFF
Other 510(k) Applications for this Contact
Regulation Number 886.4115

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

  More FDA Info for this Product Code
Date Received 05/15/2012
Decision Date 07/20/2012
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