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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Neonatal Eye
510(k) Number K926118
Device Name LIFE TRACE(R) BILIRUBIN MASK
Applicant
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1274
Buffalo,  NY  14240
Applicant Contact JOHN H BARRETT
Correspondent
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1274
Buffalo,  NY  14240
Correspondent Contact JOHN H BARRETT
Regulation Number880.5270
Classification Product Code
FOK  
Date Received12/03/1992
Decision Date 03/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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