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FDA 510(k) Application Details - K000728
Device Classification Name
Light, Surgical, Fiberoptic
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510(K) Number
K000728
Device Name
Light, Surgical, Fiberoptic
Applicant
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
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DAVID TIMLIN
Other 510(k) Applications for this Contact
Regulation Number
878.4580
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Classification Product Code
FST
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More FDA Info for this Product Code
Date Received
03/06/2000
Decision Date
03/21/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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