FDA 510(k) Application Details - K033644

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K033644
Device Name Laparoscope, General & Plastic Surgery
Applicant GEYSER S.A.
ZONE ARTISANALE DE PERACHE
COUDES 63114 FR
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Contact FRANCOIS FOURNIER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 11/20/2003
Decision Date 03/24/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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