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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 K022503
Device Name UTERINE INJECTOR
Applicant
Thomas Medical, Inc.
4100-C Nine Mcfarland Dr.
Alpharetta,  GA  30004
Applicant Contact THOMAS J ZINNANTI
Correspondent
Thomas Medical, Inc.
4100-C Nine Mcfarland Dr.
Alpharetta,  GA  30004
Correspondent Contact THOMAS J ZINNANTI
Regulation Number884.4530
Classification Product Code
LKF  
Date Received07/29/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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