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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 K041094
Device Name HSG CATHETER SET
Applicant
Bioteque America, Inc.
340 E. Maple Ave., #204-C
Langhorne,  PA  19047
Applicant Contact DENIS DORSEY
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number884.4530
Classification Product Code
LKF  
Date Received04/27/2004
Decision Date 06/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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