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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 K952977
Device Name SABRE MULTI-USE TROCAR SYSTEM
Applicant
ENDOSCOPIC CONCEPTS, INC.
11 FOREST PARK DR.
MENDON,  MA  01756
Applicant Contact J. A. WILSON
Correspondent
ENDOSCOPIC CONCEPTS, INC.
11 FOREST PARK DR.
MENDON,  MA  01756
Correspondent Contact J. A. WILSON
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received06/27/1995
Decision Date 07/17/1995
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
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