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FDA 510(k) Application Details - K010339
Device Classification Name
Catheter, Urological
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510(K) Number
K010339
Device Name
Catheter, Urological
Applicant
ENDOCARE, INC.
7 STUDEBAKER
IRVINE, CA 92618 US
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VINCENT CUTARELLI
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Regulation Number
876.5130
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Classification Product Code
KOD
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More FDA Info for this Product Code
Date Received
02/05/2001
Decision Date
03/07/2001
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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