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510(k) K851918

Device
INFANT PHOTOTHERAPY MASK
Applicant
ALBA HEALTH CARE
510(k) number
K851918
Product code
FOK  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-07
Date received
1985-05-02
Regulation
880.5270
Classification name
Pad, Neonatal Eye
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
VICTOR H GARROU
Address
Post Office Box 100 Valdese NC US 28690 28690

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
K926118LIFE TRACE(R) BILIRUBIN MASKGraphic Controls Corp.1993-03-15
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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