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FDA 510(k) Application Details - K053172
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K053172
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
OWANDY SAS
1251 AVENUE OF THE AMERICAS
34TH FLOOR
NEW YORK, NY 10020 US
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Contact
OLIVIER MAURIER
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Regulation Number
872.1800
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Classification Product Code
MUH
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Date Received
11/14/2005
Decision Date
06/09/2006
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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