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FDA 510(k) Application Details - K021438
Device Classification Name
Cannula, Intrauterine Insemination
More FDA Info for this Device
510(K) Number
K021438
Device Name
Cannula, Intrauterine Insemination
Applicant
LABOTECT LABOR-TECHNIK GOTTINGEN
WILLI-EICHLER-STR. 25
GOTTINGEN D-37079 DE
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Contact
ANGELIKA ALBRECHT
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Regulation Number
884.5250
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Classification Product Code
MFD
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More FDA Info for this Product Code
Date Received
05/06/2002
Decision Date
07/16/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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