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FDA 510(k) Application Details - K051786
Device Classification Name
Light, Surgical, Fiberoptic
More FDA Info for this Device
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
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
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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