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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K921680
Device Name E-Z PEG
Applicant
Mill-Rose Laboratory
7310 Corporate Blvd.
Mentor,  OH  44060
Applicant Contact MARK HELLER
Correspondent
Mill-Rose Laboratory
7310 Corporate Blvd.
Mentor,  OH  44060
Correspondent Contact MARK HELLER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/08/1992
Decision Date 05/06/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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