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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ligator, hemorrhoidal
510(k) Number K801352
Device Name HEMORRHOIDAL LIGATION INSTR. SYSTEM
Applicant
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.4400
Classification Product Code
FHN  
Date Received06/09/1980
Decision Date 07/08/1980
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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