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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 K884128
Device Name LAKE N/G EXTENSION SET
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 Number876.5980
Classification Product Code
KNT  
Date Received09/30/1988
Decision Date 12/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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