FDA 510(k) Application Details - K961933

Device Classification Name Catheter, Nephrostomy

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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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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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