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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameRICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namepiezolith e.l.p. lithotripter model 2300
Regulation Number876.5990
ApplicantRICHARD WOLF MEDICAL INSTRUMENTS CORP.
PMA NumberP890013
Date Received03/07/1989
Decision Date09/09/1991
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 91M-0368
Notice Date 10/10/1991
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
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