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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Intrauterine Insemination
510(k) Number K972823
Device Name MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
Applicant
A & A MEDICAL, INC.
4100 NINE MCFARLAND DR., #B
ALPHARETTA,  GA  30201
Applicant Contact ADIB KHOURY
Correspondent
A & A MEDICAL, INC.
4100 NINE MCFARLAND DR., #B
ALPHARETTA,  GA  30201
Correspondent Contact ADIB KHOURY
Regulation Number884.5250
Classification Product Code
MFD  
Date Received07/30/1997
Decision Date 10/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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