FDA 510(k) Application Details - K032283

Device Classification Name Endoscope, Fiber Optic

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510(K) Number K032283
Device Name Endoscope, Fiber Optic
Applicant DESIGNS FOR VISION, INC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINANE
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Regulation Number 876.1500

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Classification Product Code GDB
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Date Received 07/24/2003
Decision Date 08/20/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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