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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 K950836
Device Name REDFIELD INFRARED COAGULATOR
Applicant
Hogan & Hartson
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Hogan & Hartson
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number876.4300
Classification Product Code
KNS  
Date Received02/24/1995
Decision Date 03/24/1995
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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