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FDA 510(k) Application Details - K984172
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K984172
Device Name
Media, Reproductive
Applicant
NIDACON INTERNATIONAL AB
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact
DANIEL KAMM
Other 510(k) Applications for this Contact
Regulation Number
884.6180
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Classification Product Code
MQL
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More FDA Info for this Product Code
Date Received
11/20/1998
Decision Date
01/14/1999
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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