FDA 510(k) Application Details - K202299

Device Classification Name Instrument, Ultrasonic Surgical

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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
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Contact Songtao Zhan
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Regulation Number 000.0000

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Classification Product Code LFL
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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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