FDA 510(k) Application Details - K042260

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

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510(K) Number K042260
Device Name Unit, X-Ray, Extraoral With Timer
Applicant TAKARA BELMONT USA, INC.
101 BELMONT DR.
SOMERSET, NJ 08873 US
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Contact MASAHIRO KANAYA
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Regulation Number 872.1800

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Classification Product Code EHD
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Date Received 08/23/2004
Decision Date 09/07/2004
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 Y
Expedited Review



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