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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K953547
Device Name MANAN NEPHROSTOMY DRAINAGE CATHETER
Applicant
Manan Medical Products, Inc.
2200 Carlson Dr.
Northbrook,  IL  60062
Applicant Contact MICHAEL PLISHKA
Correspondent
Manan Medical Products, Inc.
2200 Carlson Dr.
Northbrook,  IL  60062
Correspondent Contact MICHAEL PLISHKA
Classification Product Code
LJE  
Date Received07/28/1995
Decision Date 08/30/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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