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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 K934772
Device Name GASTRONOMY TUBE HOLDER
Applicant
Nelmed Corp.
35 Hawthorne St.
North Attleboro,  MA  02760
Applicant Contact GORDON NELSON
Correspondent
Nelmed Corp.
35 Hawthorne St.
North Attleboro,  MA  02760
Correspondent Contact GORDON NELSON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/05/1993
Decision Date 02/28/1994
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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