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FDA 510(k) Application Details - K010220
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K010220
Device Name
Laparoscope, General & Plastic Surgery
Applicant
INSTRUMENTS MEDICAUX G.B., INC.
REGULATORY AFFAIRS
411 BELVEDERE SUD
SHERBROOKE, QUEBEC CA
Other 510(k) Applications for this Company
Contact
MARTIN PAQUETTE
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
GCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/24/2001
Decision Date
04/09/2001
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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