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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, gastro-enterostomy
510(k) Number K902121
Device Name LAKE GASTROSTOMY TUBE
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
KGC  
Date Received05/11/1990
Decision Date 07/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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