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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K930761
Device Name IMAGE-X 70 INTRAORAL X-RAY SYSTEM
Applicant
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Applicant Contact RANDAL L HALE
Correspondent
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Correspondent Contact RANDAL L HALE
Regulation Number872.1810
Classification Product Code
EAP  
Date Received02/12/1993
Decision Date 05/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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