SABRE ULTIMATE SHIELDED TROCAR

Laparoscope, General & Plastic Surgery

ENDOSCOPIC CONCEPTS, INC.

The following data is part of a premarket notification filed by Endoscopic Concepts, Inc. with the FDA for Sabre Ultimate Shielded Trocar.

Pre-market Notification Details

Device IDK943976
510k NumberK943976
Device Name:SABRE ULTIMATE SHIELDED TROCAR
ClassificationLaparoscope, General & Plastic Surgery
Applicant ENDOSCOPIC CONCEPTS, INC. 11 FOREST PARK DR. Mendon,  MA  01756
ContactJ. A Wilson
CorrespondentJ. A Wilson
ENDOSCOPIC CONCEPTS, INC. 11 FOREST PARK DR. Mendon,  MA  01756
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-15
Decision Date1994-09-07

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