FDA 510(k) Application Details - K001563

Device Classification Name Dislodger, Stone, Flexible

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510(K) Number K001563
Device Name Dislodger, Stone, Flexible
Applicant SCION CARDIOVASCULAR, INC.
14256 SW 119 AVE.
MIAMI, FL 33186 US
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Contact DAVID B JONES
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Regulation Number 876.4680

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Classification Product Code FGO
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Date Received 05/19/2000
Decision Date 11/22/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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