FDA 510(k) Application Details - K042372

Device Classification Name System,X-Ray,Extraoral Source,Digital

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510(K) Number K042372
Device Name System,X-Ray,Extraoral Source,Digital
Applicant VATECH VALUE ADDED TECHNOLOGY CO., LTD
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 08/31/2004
Decision Date 10/04/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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