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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tenaculum, Uterine
510(k) Number K891033
Device Name ATRAUMATIC TENACULA
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
21540-B PRAIRIE ST.
CHATSWORTH,  CA  91311
Applicant Contact ANNA STRAIGHT
Correspondent
ZINNANTI SURGICAL INSTRUMENTS, INC.
21540-B PRAIRIE ST.
CHATSWORTH,  CA  91311
Correspondent Contact ANNA STRAIGHT
Regulation Number884.4530
Classification Product Code
HDC  
Date Received02/28/1989
Decision Date 03/17/1989
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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