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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K902508
Device Name LAKE MALE EXTERNAL CATHETERIZATION KIT
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 Number876.5130
Classification Product Code
FCM  
Date Received06/05/1990
Decision Date 08/23/1990
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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