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FDA 510(k) Application Details - K980889
Device Classification Name
Catheter, Nephrostomy
More FDA Info for this Device
510(K) Number
K980889
Device Name
Catheter, Nephrostomy
Applicant
URESIL CORP.
5418 W. TOUHY AVE.
SKOKIE, IL 60077 US
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Contact
LEV MELINYSHYN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LJE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/1998
Decision Date
04/08/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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