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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 K932394
Device Name BERNSTEIN(TM) UTERINE MANIPULATOR
Applicant
GM ENGINEERING, INC.
2549 SIERRA WAY, SUITE B
LA VERNE,  CA  91750
Applicant Contact DAVID C STEFFIN
Correspondent
GM ENGINEERING, INC.
2549 SIERRA WAY, SUITE B
LA VERNE,  CA  91750
Correspondent Contact DAVID C STEFFIN
Regulation Number884.4530
Classification Product Code
LKF  
Date Received05/18/1993
Decision Date 01/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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