FDA.reportPublic FDA data

510(k) K925708

Device
DISPOSABLE ELECTROSURGERY BALL ELECTRODE
Applicant
BEACON LABORATORIES, INC.
510(k) number
K925708
Product code
DWG  
Decision
Substantially Equivalent (SESE)
Decision date
1993-04-20
Date received
1992-11-12
Regulation
878.4400
Classification name
Electrosurgical Device
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD P FLEENOR
Address
2150 W. 6th Ave., Unit P Broomfield CO US 80020 80020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942823MAHE INSTRUMENTSMahe Intl., Inc.1994-12-05
K932345TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USEConmedcorp1994-04-12
K931215HAND-TROL SAspen Labs1994-03-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases