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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K800964
Device Name M.R. ASSOC. BALL TYPE COAGULATOR
Applicant
MR ASSOCIATES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MR ASSOCIATES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/23/1980
Decision Date 05/08/1980
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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