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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 K951734
Device Name LUMIX 70B
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 Number872.1810
Classification Product Code
EAP  
Date Received04/14/1995
Decision Date 07/20/1995
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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