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FDA 510(k) Application Details - K212907
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K212907
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
Kam Yuen Plastic Products Ltd.
No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town
ZhongShan 518100 CN
Other 510(k) Applications for this Company
Contact
Anna Dan
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2021
Decision Date
12/02/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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