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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K003577
Device Name STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
Applicant
STERIS Corporation
2720 Gunter Park E.
Montgomery,  AL  36109
Applicant Contact RAYMOND URSICK
Correspondent
STERIS Corporation
2720 Gunter Park E.
Montgomery,  AL  36109
Correspondent Contact RAYMOND URSICK
Regulation Number878.4580
Classification Product Code
FST  
Date Received11/20/2000
Decision Date 01/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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