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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic, Dental
510(k) Number K874118
Device Name MODEL 410 DENTAL X-RAY FILM PROCESSORS
Applicant
Dent-X Co.
250 Clearbrook Rd.
Elmsford,  NY  10523
Applicant Contact DONALD R HILL
Correspondent
Dent-X Co.
250 Clearbrook Rd.
Elmsford,  NY  10523
Correspondent Contact DONALD R HILL
Regulation Number892.1900
Classification Product Code
EGY  
Date Received10/09/1987
Decision Date 11/06/1987
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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