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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K926181
Device Name ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY
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 Number876.1500
Classification Product Code
GCJ  
Date Received12/08/1992
Decision Date 12/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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