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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 K040238
Device Name SOFTSEAL HSG CATHETER
Applicant
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Applicant Contact AL MUZZAMMEL
Correspondent
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Correspondent Contact AL MUZZAMMEL
Regulation Number884.4530
Classification Product Code
LKF  
Date Received01/26/2004
Decision Date 06/22/2004
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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