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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 K940540
Device Name VELO ACE
Applicant
Emix U.S.A., Inc.
222 Fox Run Rd.
King Of Prussia,  PA  19406
Applicant Contact JACK H FAUDE
Correspondent
Emix U.S.A., Inc.
222 Fox Run Rd.
King Of Prussia,  PA  19406
Correspondent Contact JACK H FAUDE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received02/07/1994
Decision Date 07/18/1994
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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