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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dislodger, stone, flexible
510(k) Number K001563
Device Name SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
Applicant
SCION CARDIOVASCULAR, INC.
14256 SW 119 AVE.
MIAMI,  FL  33186
Applicant Contact DAVID B JONES
Correspondent
SCION CARDIOVASCULAR, INC.
14256 SW 119 AVE.
MIAMI,  FL  33186
Correspondent Contact DAVID B JONES
Regulation Number876.4680
Classification Product Code
FGO  
Date Received05/19/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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