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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 K931814
Device Name DMI UTERINE MOBILIZER/ELEVATOR/CANNULA
Applicant
Diversified Medical Instruments, Inc.
4519 Taraley Ct.
Ellicott City,  MD  21042
Applicant Contact CHARLES J SALBERG
Correspondent
Diversified Medical Instruments, Inc.
4519 Taraley Ct.
Ellicott City,  MD  21042
Correspondent Contact CHARLES J SALBERG
Regulation Number884.4530
Classification Product Code
LKF  
Date Received04/08/1993
Decision Date 05/31/1994
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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