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FDA 510(k) Application Details - K062403
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K062403
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
OWANDY
110 E. GRANADA BLVD.
SUITE 207
ORMOND BEACH, FL 32176 US
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Contact
CLAUDE D BERTHOIN
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Regulation Number
872.1800
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Classification Product Code
MUH
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More FDA Info for this Product Code
Date Received
08/17/2006
Decision Date
11/14/2006
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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