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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 K941458
Device Name UTERINE MANIPULATOR/INJECTOR WITH SPRING
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
21540-B PRAIRIE ST.
CHATSWORTH,  CA  91311
Applicant Contact TRISH WILLGING
Correspondent
ZINNANTI SURGICAL INSTRUMENTS, INC.
21540-B PRAIRIE ST.
CHATSWORTH,  CA  91311
Correspondent Contact TRISH WILLGING
Regulation Number884.4530
Classification Product Code
LKF  
Date Received03/25/1994
Decision Date 01/25/1995
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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