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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 K851444
Device Name KEITH-A.R.V.
Applicant
Karl M. Block Co.
567 Hanley Industrial Court
St. Louis,  MO  63144
Applicant Contact KEITH
Correspondent
Karl M. Block Co.
567 Hanley Industrial Court
St. Louis,  MO  63144
Correspondent Contact KEITH
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/11/1985
Decision Date 05/10/1985
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
Recalls CDRH Recalls
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