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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
510(k) Number K925885
Device Name AFP 17 X 4 AUTOMATIC FILM PROCESSOR
Applicant
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Applicant Contact RANDALL L HALE
Correspondent
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Correspondent Contact RANDALL L HALE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received11/16/1992
Decision Date 06/09/1993
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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