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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coagulator, culdoscopic (and accessories)
510(k) Number K925960
Device Name FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
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 Number884.4160
Classification Product Code
HFI  
Date Received11/24/1992
Decision Date 06/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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