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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 K103217
Device Name LITE-MED LM-9200 ELMA
Applicant
Lite-Med, Inc.
9th Floor, 49 Dongxing Rd.
Xinyi District
Taipei City,  TW 110
Applicant Contact WALT HSU
Correspondent
Lite-Med, Inc.
9th Floor, 49 Dongxing Rd.
Xinyi District
Taipei City,  TW 110
Correspondent Contact WALT HSU
Regulation Number876.5990
Classification Product Code
LNS  
Date Received11/01/2010
Decision Date 09/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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