FDA 510(k) Application Details - K962631

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

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510(K) Number K962631
Device Name Unit, X-Ray, Extraoral With Timer
Applicant FAIR IMAGE, INC.
1000 BURNETT AVE.
SUITE 450
CONCORD, CA 94520 US
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Contact DAVID W SCHLERF
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Regulation Number 872.1800

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Classification Product Code EHD
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Date Received 07/05/1996
Decision Date 11/26/1996
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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