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FDA 510(k) Application Details - K063442
Device Classification Name
Catheter, Retention Type, Balloon
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510(K) Number
K063442
Device Name
Catheter, Retention Type, Balloon
Applicant
DEGANIA SILICONE, LTD.
DEGANIA BET
EMEK HAYARDEN 15130 IL
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Contact
ZOYA LEE
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Regulation Number
876.5130
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Classification Product Code
EZL
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More FDA Info for this Product Code
Date Received
11/14/2006
Decision Date
03/26/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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