FDA 510(k) Application Details - K973798

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

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510(K) Number K973798
Device Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant SOPRO
PLACE ST. CHRISTOPHE
LES ACCATES-LA VALENTINE
MARSEILLE 13011 FR
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Contact PIERRE MONTILLOT
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Regulation Number 876.1500

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Classification Product Code FET
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Date Received 10/06/1997
Decision Date 12/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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