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FDA 510(k) Application Details - K210488
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K210488
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
No.1 XinXing Yilu Road, Emerging Industrial Cluster Area
Cixi 315301 CN
Other 510(k) Applications for this Company
Contact
Guofang Ma
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
02/19/2021
Decision Date
10/25/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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