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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Drainage Collection Kit, For Indwelling Catheter
510(k) Number K883610
Device Name LAKE FOLEY CATHETERIZATION TRAY
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 Number876.5250
Classification Product Code
FCN  
Date Received08/22/1988
Decision Date 10/12/1988
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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