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FDA 510(k) Application Details - K220202
Device Classification Name
Cannula, Manipulator/Injector, Uterine
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510(K) Number
K220202
Device Name
Cannula, Manipulator/Injector, Uterine
Applicant
The O R Company Pty Ltd
1/32 Silkwood Rise
Carrum Downs 3201 AU
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Contact
Nicole Conway
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Regulation Number
000.0000
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Classification Product Code
LKF
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More FDA Info for this Product Code
Date Received
01/24/2022
Decision Date
03/31/2022
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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