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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 K842810
Device Name INFRARED COAGULATOR
Applicant
ENDO LASE, INC.
815 CONNECTICUT AVE., N.W.
WASHINGTON,  DC  20006
Applicant Contact JONATHAN S KAHAN
Correspondent
ENDO LASE, INC.
815 CONNECTICUT AVE., N.W.
WASHINGTON,  DC  20006
Correspondent Contact JONATHAN S KAHAN
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/18/1984
Decision Date 10/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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