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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 K955845
Device Name LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
Applicant
Surgical Image Laboratories, Inc.
1286 W. Newport Ctr. Dr.
Deerfield Beach,  FL  33442
Applicant Contact LEE STANKO
Correspondent
Surgical Image Laboratories, Inc.
1286 W. Newport Ctr. Dr.
Deerfield Beach,  FL  33442
Correspondent Contact LEE STANKO
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/22/1995
Decision Date 07/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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