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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 K013491
Device Name HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
Applicant
A & A Medical, Inc.
9370 Industrial Trace
Alpharetta,  GA  30004 -3383
Applicant Contact JAY MANSOUR
Correspondent
A & A Medical, Inc.
9370 Industrial Trace
Alpharetta,  GA  30004 -3383
Correspondent Contact JAY MANSOUR
Regulation Number884.4530
Classification Product Code
LKF  
Date Received10/22/2001
Decision Date 11/19/2001
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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