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FDA 510(k) Application Details - K220577
Device Classification Name
Handpiece, Belt And/Or Gear Driven, Dental
More FDA Info for this Device
510(K) Number
K220577
Device Name
Handpiece, Belt And/Or Gear Driven, Dental
Applicant
Micro-NX Co., Ltd.
22 Maeyeo-ro 1 gil
Dong-gu 41059 KR
Other 510(k) Applications for this Company
Contact
Sojeong Park
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/2022
Decision Date
07/29/2022
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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