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510(k) K842515

Device
SURGICAL HEADLIGHT
Applicant
GOOD-LITE CO.
510(k) number
K842515
Product code
EBA  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-02
Date received
1984-06-12
Regulation
872.4630
Classification name
Light, Surgical Headlight
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070287PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500Photonic Optische Gerate GmbH & Cokg2007-02-12
K923949SYLVAN DENTAL HEADLIGHT SYSTEMSylvan Medical Fiberoptics1992-10-16
K893458FIBEROPTIC HEADLIGHT SYSTEMCuda Products Co.1989-06-22
K854646VEGA DENTAL OPERATING LIGHTAlpine Dental Equipment Co.1986-03-06
K842358ISOLIGHTPlanmeca USA, Inc.1984-07-31
K822265FIBEROPTIC LIGHT SOURCE W/RELATED ITEMSKelleher Corp.1982-09-28
K810117HALOGEN HEADLIGHT SYSTEMColmed, Ltd.1981-02-10
K790806PORCELITHarry J. Bosworth Co.1979-08-03
K790807METALITHarry J. Bosworth Co.1979-08-03

Legacy Summary#

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FDA Review#

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