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FDA 510(k) Application Details - K132869
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K132869
Device Name
Material, Impression
Applicant
HRS CO., LTD.
216-5 BLOCK 6 CHOOPAL INDUSTRIAL COMPLEX
394-1 CHOOPAL-RI
PYONGTAEK 451-805 KR
Other 510(k) Applications for this Company
Contact
JAE-HYEON CHOI
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2013
Decision Date
06/19/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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