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FDA 510(k) Application Details - K202479
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K202479
Device Name
Implant, Endosseous, Root-Form
Applicant
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu
Daejeon 34027 KR
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Contact
Bo-Yeon Lim
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Regulation Number
872.3640
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Classification Product Code
DZE
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More FDA Info for this Product Code
Date Received
08/28/2020
Decision Date
09/23/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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