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510(k) K841588

Device
SUN-LITE WHITE SPOT
Applicant
SUNCOAST MEDICAL MANUFACTURERS, INC.
510(k) number
K841588
Product code
KYT  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-22
Date received
1984-04-18
Regulation
880.6350
Classification name
Light, Examination, Medical, Battery Powered
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920782OLYMPIC TRANS-LITEOlympic Medical Corp.1992-03-27
K841589C-LITESuncoast Medical Manufacturers, Inc.1984-05-22
K791001PENLIGHT/SWAB HOLDERConcept, Inc.1979-06-22
K781228PENLIGHTSAbco Dealers, Inc.1978-09-07
K760972TYCOS DIAGNOSTIC PENLIGHTTaylor Instrument Analytics Co.1977-01-26

Legacy Summary#

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FDA Review#

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