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FDA 510(k) Application Details - K011264
Device Classification Name
Stent, Ureteral
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510(K) Number
K011264
Device Name
Stent, Ureteral
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact
ANIL BHALANI
Other 510(k) Applications for this Contact
Regulation Number
876.4620
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Classification Product Code
FAD
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More FDA Info for this Product Code
Date Received
04/25/2001
Decision Date
07/17/2001
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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