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FDA 510(k) Application Details - K202299
Device Classification Name
Instrument, Ultrasonic Surgical
More FDA Info for this Device
510(K) Number
K202299
Device Name
Instrument, Ultrasonic Surgical
Applicant
SMTP Technology Co., Ltd
1F&4F, Building A, Emerging Industry Incubation Center
Zhangjiagang 215634 CN
Other 510(k) Applications for this Company
Contact
Songtao Zhan
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
08/13/2020
Decision Date
05/21/2021
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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