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510(k) K121441

Device
CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
Applicant
BOVIE MEDICAL CORPORATION
510(k) number
K121441
Product code
HQP  
Decision
Substantially Equivalent (SESE)
Decision date
2012-07-20
Date received
2012-05-15
Regulation
886.4115
Classification name
Unit, Cautery, Thermal, Battery-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD A KOZLOFF
Address
5115 Ulmerton Rd. -- Clearwater FL US 33760 33760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HQP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERYFiab Spa2009-09-01
K062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIESKirwan Surgical Products, Inc.2007-03-09
K023506SURGICAL MEDICAL DEVICE CAUTERYModern Medical Equipment Mfg., Ltd.2004-01-13
K002547STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTORStarion Instruments2000-10-20
K994019CAUTERY GRASPER/DISSECTORStarion Instruments2000-01-20
K990728THERMAL CAUTERY DEVICE, FORCEPSStarion Instruments1999-06-03
K952784OXBORO-MEDICAL CAUTERY TIP CLEANEROxboro Medical Intl., Inc.1995-07-13
K945761LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIPAaron Medical Industries1995-04-10
K945763LOW TEMPERATURE CAUTERY ELONGATED FINE TIPAaron Medical Industries1995-02-07
K945762LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLEAaron Medical Industries1995-02-07
K945493OPHTHALMIC CAUTERYAaron Medical Industries1995-01-30
K933079ELECTROCAUTERY SYSTEM MODEL 1980Pmt Corp.1994-02-22
K875260EFFNER CAUTERY INSTRUMENTSEffner and Spreine Co.1988-06-06
K840425OPTHERM FINE TIPSuncoast Medical Manufacturers, Inc.1984-05-09
K840426OPTHERM EXTRA FINE TIPSuncoast Medical Manufacturers, Inc.1984-05-09

Legacy Summary#

summary

FDA Review#

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