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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number K213772
Device Name LM-9300 Plus Lithotripter
Applicant
Lite-Med, Inc.
9th Floor, 49 Dongxing Rd., Xinyi District
Taipei,  TW 11070
Applicant Contact Walt Hsu
Correspondent
Lite-Med, Inc.
9th Floor, 49 Dongxing Rd., Xinyi District
Taipei,  TW 11070
Correspondent Contact Walt Hsu
Regulation Number876.5990
Classification Product Code
LNS  
Date Received12/02/2021
Decision Date 01/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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