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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, Extraoral Source, Digital
510(k) Number K041120
Device Name EV APAN DIGITAL, MODEL K1VSM2000
Applicant
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Applicant Contact JAMES JOHNSON
Correspondent
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Correspondent Contact JAMES JOHNSON
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/29/2004
Decision Date 08/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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