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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 K011106
Device Name STONELITH, MODEL V5
Applicant
Pck Electronic Industry and Trade Co, Ltd.
59/1 Sancak, Cankaya
Ankara,  TR 06550
Applicant Contact CENGIZ KABAKCI
Correspondent
Pck Electronic Industry and Trade Co, Ltd.
59/1 Sancak, Cankaya
Ankara,  TR 06550
Correspondent Contact CENGIZ KABAKCI
Regulation Number876.5990
Classification Product Code
LNS  
Date Received04/11/2001
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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