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FDA 510(k) Application Details - K181891
Device Classification Name
Unit, X-Ray, Extraoral With Timer
More FDA Info for this Device
510(K) Number
K181891
Device Name
Unit, X-Ray, Extraoral With Timer
Applicant
Digimed Co., LTD.
309-311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu
Seoul 08506 KR
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Contact
Youngbae Kwon
Other 510(k) Applications for this Contact
Regulation Number
872.1800
More FDA Info for this Regulation Number
Classification Product Code
EHD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/13/2018
Decision Date
08/10/2018
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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