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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K954132
Device Name MANAN MANTA CATHETER FIXATION DISK
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
Regulation Number876.5130
Classification Product Code
KNY  
Subsequent Product Code
FGE  
Date Received09/01/1995
Decision Date 03/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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