FDA 510(k) Application Details - K051786

Device Classification Name Light, Surgical, Fiberoptic

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510(K) Number K051786
Device Name Light, Surgical, Fiberoptic
Applicant DESIGNS FOR VISION, INC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact CYNTHIA J M. NOLTE
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Regulation Number 878.4580

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Classification Product Code FST
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Date Received 07/01/2005
Decision Date 08/15/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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