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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 K020292
Device Name UTERINE INJECTOR
Applicant
CATHETER RESEARCH, INC.
6131 WEST 80TH ST.
INDIANAPOLIS,  IN  46278
Applicant Contact JOHN A STEEN
Correspondent
CATHETER RESEARCH, INC.
6131 WEST 80TH ST.
INDIANAPOLIS,  IN  46278
Correspondent Contact JOHN A STEEN
Regulation Number884.4530
Classification Product Code
LKF  
Date Received01/28/2002
Decision Date 04/17/2002
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
Recalls CDRH Recalls
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