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FDA 510(k) Application Details - K961933
Device Classification Name
Catheter, Nephrostomy
More FDA Info for this Device
510(K) Number
K961933
Device Name
Catheter, Nephrostomy
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER, IN 47460 US
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Contact
RICK LYKINS
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Regulation Number
000.0000
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Classification Product Code
LJE
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More FDA Info for this Product Code
Date Received
05/17/1996
Decision Date
07/18/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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