FDA 510(k) Application Details - K040760

Device Classification Name Stent, Ureteral

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510(K) Number K040760
Device Name Stent, Ureteral
Applicant APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact CHERYL BLAKE
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Regulation Number 876.4620

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Classification Product Code FAD
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Date Received 03/25/2004
Decision Date 10/15/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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