FDA 510(k) Application Details - K011106

Device Classification Name Lithotriptor, Extracorporeal Shock-Wave,Urological

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510(K) Number K011106
Device Name Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD
59/1 SANCAK, CANKAYA
ANKARA 06550 TR
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Contact CENGIZ KABAKCI
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Regulation Number 876.5990

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Classification Product Code LNS
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Date Received 04/11/2001
Decision Date 02/11/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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