FDA 510(k) Application Details - K021372

Device Classification Name Cephalometer

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510(K) Number K021372
Device Name Cephalometer
Applicant J. MORITA USA, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON, DC 20005 US
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Contact KEITH A BARRITT
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Regulation Number 872.1830

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Classification Product Code EAG
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Date Received 04/30/2002
Decision Date 06/07/2002
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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