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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 K901835
Device Name LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)
Applicant
Lake Medical Products, Inc.
1145 Moog Dr.
St. Louis,  MO  63146
Applicant Contact ELI SCHACHET
Correspondent
Lake Medical Products, Inc.
1145 Moog Dr.
St. Louis,  MO  63146
Correspondent Contact ELI SCHACHET
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/19/1990
Decision Date 09/05/1990
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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