FDA 510(k) Application Details - K071218

Device Classification Name Light, Surgical, Fiberoptic

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510(K) Number K071218
Device Name Light, Surgical, Fiberoptic
Applicant WELCH ALLYN, INC.
4341 STATE STREET ROAD
PO BOX 220
SKANEATELES FALLS, NY 13153-0220 US
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Contact JOHN E SAWYER
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Regulation Number 878.4580

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Classification Product Code FST
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Date Received 05/02/2007
Decision Date 06/14/2007
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 N
Expedited Review



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