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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 K862091
Device Name MCGAW NUTRA-FEED EFS ENTERAL FEEDING TUBE
Applicant
Kendall Mcgaw Laboratories, Inc.
P.O. Box 25080
Santa Ana,  CA  92799
Applicant Contact JOYCE WILLIAMS
Correspondent
Kendall Mcgaw Laboratories, Inc.
P.O. Box 25080
Santa Ana,  CA  92799
Correspondent Contact JOYCE WILLIAMS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/02/1986
Decision Date 08/14/1986
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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