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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 K010296
Device Name UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
Applicant
Marina Medical Instruments, Inc.
2761 N. 29th Ave.
Hollywood,  FL  33020
Applicant Contact JIHAD (JAY) MANSOUR
Correspondent
Marina Medical Instruments, Inc.
2761 N. 29th Ave.
Hollywood,  FL  33020
Correspondent Contact JIHAD (JAY) MANSOUR
Regulation Number884.4530
Classification Product Code
LKF  
Date Received01/31/2001
Decision Date 04/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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