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FDA 510(k) Application Details - K212614
Device Classification Name
Instrument, Ultrasonic Surgical
More FDA Info for this Device
510(K) Number
K212614
Device Name
Instrument, Ultrasonic Surgical
Applicant
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
No.1 XinXing Yilu Road, Emerging Industrial Cluster Area
Zonghan Subdistrict
Cixi 315301 CN
Other 510(k) Applications for this Company
Contact
Guofang Ma
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/18/2021
Decision Date
07/18/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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