FDA 510(k) Application Details - K953601

Device Classification Name Catheter, Nephrostomy

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510(K) Number K953601
Device Name Catheter, Nephrostomy
Applicant MANAN MEDICAL PRODUCTS, INC.
2200 CARLSON DR.
NORTHBROOK, IL 60062 US
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Contact MICHAEL PLISHKA
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Regulation Number 000.0000

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Classification Product Code LJE
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Date Received 08/02/1995
Decision Date 03/26/1996
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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