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FDA 510(k) Application Details - K210367
Device Classification Name
Laser, Dental, Soft Tissue
More FDA Info for this Device
510(K) Number
K210367
Device Name
Laser, Dental, Soft Tissue
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
Information Industrial Park, Guilin National High-Tech Zone
Guilin 541004 CN
Other 510(k) Applications for this Company
Contact
Yang Yunfeng
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
NVK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/08/2021
Decision Date
03/10/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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