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FDA 510(k) Application Details - K111788
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
More FDA Info for this Device
510(K) Number
K111788
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
OLYMPUS AMERICA, INC.
3500 CORPORATE PARKWAY
CENTER VALLEY, PA 18034-0610 US
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Contact
STACY ABBATIELLO KLUESNER
Other 510(k) Applications for this Contact
Regulation Number
884.1720
More FDA Info for this Regulation Number
Classification Product Code
HET
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2011
Decision Date
01/13/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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