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FDA 510(k) Application Details - K051585
Device Classification Name
Laparoscope, General & Plastic Surgery
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510(K) Number
K051585
Device Name
Laparoscope, General & Plastic Surgery
Applicant
MAUNA KEA TECHNOLOGIES
9, RUE D'ENGHIEN
PARIS 75010 FR
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Contact
ALEXANDRE LOISEAU
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Regulation Number
876.1500
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Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
06/15/2005
Decision Date
09/06/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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