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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Surgical
510(k) Number K013242
Device Name AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
Applicant
STERIS Corporation
2720 GUNTER PARK EAST
MONTGOMERY,  AL  36109
Applicant Contact ROBERT H MCCALL
Correspondent
STERIS Corporation
2720 GUNTER PARK EAST
MONTGOMERY,  AL  36109
Correspondent Contact ROBERT H MCCALL
Regulation Number878.4580
Classification Product Code
FTD  
Date Received09/28/2001
Decision Date 12/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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