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FDA 510(k) Application Details - K001115
Device Classification Name
Cannula, Manipulator/Injector, Uterine
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510(K) Number
K001115
Device Name
Cannula, Manipulator/Injector, Uterine
Applicant
LYCO ENTERPRISES, INC.
4727 OSBORNE DR.,
BLDG. A, SUITE 100
EL PASO, TX 79922-1011 US
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ROBERT L CHILD
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LKF
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More FDA Info for this Product Code
Date Received
04/06/2000
Decision Date
05/17/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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