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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
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