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510(k) K003423

ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 by St. Francis Medical Equipment Co., Ltd. — Product Code FTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2001
Date Received
November 3, 2000
Clearance Type
Traditional
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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