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510(k) K896961

Device
HALUX EXLITE MINOR SURGERY LIGHT
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K896961
Product code
GBC  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-22
Date received
1989-12-15
Regulation
878.4580
Classification name
Lamp, Surgical, Incandescent
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CRAIG RAPP
Address
1430 Hanley Industrial Ct. St. Louis MO US 63144 63144

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830610FLAT SUCTION DRAINSil-Med Corp.1983-03-29
K811311SKYTRON ELITE SURGICAL TABLESSkytron, Div. the Kmw Group, Inc.1981-06-02
K810207MINOR SURGERY LIGHTCavitron Corp.1981-02-13

Legacy Summary#

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FDA Review#

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