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510(k) K926118

Device
LIFE TRACE(R) BILIRUBIN MASK
Applicant
GRAPHIC CONTROLS CORP.
510(k) number
K926118
Product code
FOK  
Decision
Substantially Equivalent (SESE)
Decision date
1993-03-15
Date received
1992-12-03
Regulation
880.5270
Classification name
Pad, Neonatal Eye
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN H BARRETT
Address
189 Van Rensselaer St. P.O. Box 1274 Buffalo NY US 14240 14240

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FOK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962290DEROYAL INDUSTRIES, INC. NEONATAL EYE COVERDebusk Technology Corp.1996-07-03
K851918INFANT PHOTOTHERAPY MASKAlba Health Care1985-06-07
K840894PHOTO-THERAPY EYE PROTECTORA & A Medical Supplies Co.1984-03-23
K813214INFANT PHOTOTHERAPY MASKMontrose Phototherapy Supply1981-12-09

Legacy Summary#

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FDA Review#

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