FDA 510(k) Application Details - K020301

Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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510(K) Number K020301
Device Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant VISTA MEDICAL TECHNOLOGIES, INC.
134 FLANDERS RD.
WESTBOROUGH, MA 01581 US
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Contact GRAHAM BAILLIE
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Regulation Number 876.1500

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Classification Product Code FET
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Date Received 01/29/2002
Decision Date 02/12/2002
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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