FDA 510(k) Application Details - K972245

Device Classification Name Cannula, Intrauterine Insemination

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510(K) Number K972245
Device Name Cannula, Intrauterine Insemination
Applicant A & A MEDICAL, INC.
4100 NINE MCFARLAND DR., #B
ALPHARETTA, GA 30201 US
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Regulation Number 884.5250

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Classification Product Code MFD
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Date Received 06/16/1997
Decision Date 08/06/1997
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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