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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K010056
Device Name UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
Applicant
A & A Medical, Inc.
9370 Industrial Trace
Alpharetta,  GA  30004 -3383
Applicant Contact JIHAD MANSOUR
Correspondent
A & A Medical, Inc.
9370 Industrial Trace
Alpharetta,  GA  30004 -3383
Correspondent Contact JIHAD MANSOUR
Regulation Number884.4530
Classification Product Code
LKF  
Date Received01/08/2001
Decision Date 02/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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