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FDA 510(k) Application Details - K974419
Device Classification Name
Catheter, Retention Type, Balloon
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510(K) Number
K974419
Device Name
Catheter, Retention Type, Balloon
Applicant
RUSCH, INC.
2450 MEADOWBROOK PKWY.
DULUTH, GA 30096 US
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Contact
RONALD J YOUNG
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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
11/24/1997
Decision Date
01/27/1998
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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