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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K961216
Device Name MANAN INTRODUCER SHEALTH/NEEDLE
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 Number876.5010
Classification Product Code
FGE  
Date Received03/28/1996
Decision Date 05/23/1996
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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