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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 K953601
Device Name MANAN UNIVERSAL SUMP 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  
Subsequent Product Code
GBO  
Date Received08/02/1995
Decision Date 03/26/1996
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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