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FDA 510(k) Application Details - K993063
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K993063
Device Name
Catheter, Retention Type, Balloon
Applicant
RUSCH INTL.
TALL PINES PARK
JAFFREY, NH 03452 US
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Contact
JULIE A BEAUMONT
Other 510(k) Applications for this Contact
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
09/13/1999
Decision Date
12/09/1999
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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