FDA 510(k) Application Details - K080076

Device Classification Name Unit, X-Ray, Extraoral With Timer

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510(K) Number K080076
Device Name Unit, X-Ray, Extraoral With Timer
Applicant CEFLA S.C.R.L.
110 E GRANADA BLVD.
SUITE 207
ORMOND BEACH, FL 32176 US
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Contact CLAUDE BERTOIN
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Regulation Number 872.1800

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Classification Product Code EHD
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Date Received 01/11/2008
Decision Date 03/14/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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