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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 K041582
Device Name MODIFICATION TO TRIPTER X-1 COMPACT DUET
Applicant
Direx Systems Corp.
11 Mercer Rd.
Natick,  MA  01760
Applicant Contact LARISA GERSHTEIN
Correspondent
Direx Systems Corp.
11 Mercer Rd.
Natick,  MA  01760
Correspondent Contact LARISA GERSHTEIN
Regulation Number876.5990
Classification Product Code
LNS  
Date Received06/14/2004
Decision Date 07/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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