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FDA 510(k) Application Details - K971801
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K971801
Device Name
Catheter, Retention Type, Balloon
Applicant
LOUISVILLE LABORATORIES, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
MARY MCNAMARA-CULLINANE
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
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More FDA Info for this Product Code
Date Received
05/15/1997
Decision Date
07/22/1997
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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