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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K872750
Device Name LAKE CATHETER CARE KIT
Applicant
Lake Medical Products, Inc.
11866 Adie Rd.
Maryland Heights,  MO  63043
Applicant Contact ELI SCHACHET
Correspondent
Lake Medical Products, Inc.
11866 Adie Rd.
Maryland Heights,  MO  63043
Correspondent Contact ELI SCHACHET
Regulation Number876.5130
Classification Product Code
KOD  
Date Received07/13/1987
Decision Date 09/03/1987
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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