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FDA 510(k) Application Details - K964575
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K964575
Device Name
Catheter, Retention Type, Balloon
Applicant
RUSCH INTL.
TALL PINES PARK
JAFFREY, NH 03452 US
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Contact
KARENANN J BROZOWSKI
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/1996
Decision Date
02/04/1997
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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