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FDA 510(k) Application Details - K133007
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K133007
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
DEXCOWIN CO., LTD
110 EAST GRANADA BLVD.
SUITE 207
ORMOND BEACH, FL 32176 US
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Contact
Claude 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
09/25/2013
Decision Date
04/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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