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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Intensifying, Radiographic
510(k) Number K902039
Device Name RAREX & OPTEX X-RAY SCREENS
Applicant
Mci Optonix, Inc.
Hanover Ave. And Horsehill Rd.
P.O. Box 1
Cedar Knolls,  NJ  07927
Applicant Contact JOHN DAFORNO
Correspondent
Mci Optonix, Inc.
Hanover Ave. And Horsehill Rd.
P.O. Box 1
Cedar Knolls,  NJ  07927
Correspondent Contact JOHN DAFORNO
Regulation Number892.1960
Classification Product Code
EAM  
Date Received05/04/1990
Decision Date 07/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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