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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTECHNOMED INTERNATIONAL SONOLITH 3000 (LITHORAY)TM
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotripter
Regulation Number876.5990
ApplicantTECHNOMED INTL., INC.
PMA NumberP880011
Supplement NumberS007
Date Received11/01/1991
Decision Date02/10/1992
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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