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FDA 510(k) Application Details - K151707
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K151707
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
RAYENCE CO., LTD
14, SAMSUNG 1-RO, 1-GIL
HWASEONG-SI 445-170 KR
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Contact
KEVIN KIM
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Regulation Number
872.1800
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Classification Product Code
MUH
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Date Received
06/24/2015
Decision Date
07/19/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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