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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K840144
Device Name YAG LASER 8000 GASTROINTESTINAL BLEE
Applicant
Cooper Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cooper Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.1075
Classification Product Code
FCG  
Date Received01/13/1984
Decision Date 05/18/1984
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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