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510(k) K013242

AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM by STERIS Corporation — Product Code FTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2001
Date Received
September 28, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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