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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K953444
Device Name MCI OPTONIX ECONOMY CASSETTE
Applicant
Mci Optonix, Inc.
P.O. Box I
170 E. Hanover Ave.
Cedar Knolls,  NJ  07927
Applicant Contact JOEL FREY
Correspondent
Mci Optonix, Inc.
P.O. Box I
170 E. Hanover Ave.
Cedar Knolls,  NJ  07927
Correspondent Contact JOEL FREY
Regulation Number892.1850
Classification Product Code
IXA  
Date Received07/17/1995
Decision Date 08/02/1995
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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