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FDA 510(k) Application Details - K972823
Device Classification Name
Cannula, Intrauterine Insemination
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510(K) Number
K972823
Device Name
Cannula, Intrauterine Insemination
Applicant
A & A MEDICAL, INC.
4100 NINE MCFARLAND DR., #B
ALPHARETTA, GA 30201 US
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Contact
ADIB KHOURY
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Regulation Number
884.5250
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Classification Product Code
MFD
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Date Received
07/30/1997
Decision Date
10/10/1997
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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