FDA 510(k) Application Details - K022443

Device Classification Name Media, Reproductive

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510(K) Number K022443
Device Name Media, Reproductive
Applicant NIDACON INTERNATIONAL AB
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 884.6180

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Classification Product Code MQL
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Date Received 07/25/2002
Decision Date 08/28/2002
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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