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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 K942883
Device Name DIGITAL I.D. CAMERA
Applicant
Miles Inc., Agfa Division
100 Challenger Rd.
Ridgefield Park,  NJ  07660
Applicant Contact MICHAEL SULLIVAN
Correspondent
Miles Inc., Agfa Division
100 Challenger Rd.
Ridgefield Park,  NJ  07660
Correspondent Contact MICHAEL SULLIVAN
Regulation Number892.1640
Classification Product Code
JAC  
Date Received06/17/1994
Decision Date 09/30/1994
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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