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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment
510(k) Number K201274
Device Name Ultrasonic Osteotomy Surgical System
Applicant
Smtp Technology Co., Ltd.
1f&4f, Bldg. A, Emerging Industry Incubation Center
Zhangjiagang,  CN 215634
Applicant Contact Songtao Zhan
Correspondent
Smtp Technology Co., Ltd.
1f&4f, Bldg. A, Emerging Industry Incubation Center
Zhangjiagang,  CN 215634
Correspondent Contact Songtao Zhan
Regulation Number888.4580
Classification Product Code
JDX  
Date Received05/12/2020
Decision Date 02/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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