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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotripter
Regulation Number876.5990
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP840008
Date Received02/22/1984
Decision Date12/19/1984
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 84M-0438
Notice Date 01/16/1985
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S018 S019 
S021 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 
S034 S035 S037 S038 S039 S040 
S041 S042 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 
S054 S056 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 
S067 S068 S069 
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