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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 K911600
Device Name ILCO INFRARED LIGHT COAGULATOR
Applicant
Holl Meditronics, Inc.
P.O. Box 396
Bolton, Ontario,  CA L7E 5T3
Applicant Contact WILLIAM H HOLL
Correspondent
Holl Meditronics, Inc.
P.O. Box 396
Bolton, Ontario,  CA L7E 5T3
Correspondent Contact WILLIAM H HOLL
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/10/1991
Decision Date 07/09/1991
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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