FDA 510(k) Application Details - K070811

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

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510(K) Number K070811
Device Name System,X-Ray,Extraoral Source,Digital
Applicant DEXCO
11 DELLCASTLE COURT
MONTGOMERY VILLAGE, MD 20886 US
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Contact ROBERT MAZZAFERRO
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 03/26/2007
Decision Date 07/05/2007
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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