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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Film Marking, Radiographic
510(k) Number K913478
Device Name RADIOGRAPHIC FILM MARKING SYSTEM
Applicant
Lorad Medical Systems, Inc.
Eagle Rd., Commerce Park
Danbury,  CT  06810
Applicant Contact ED MCDERMOTT
Correspondent
Lorad Medical Systems, Inc.
Eagle Rd., Commerce Park
Danbury,  CT  06810
Correspondent Contact ED MCDERMOTT
Regulation Number892.1640
Classification Product Code
JAC  
Date Received08/06/1991
Decision Date 10/15/1991
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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