DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM

Laparoscope, General & Plastic Surgery

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Dyonics Vision 635 Image Management System.

Pre-market Notification Details

Device IDK023053
510k NumberK023053
Device Name:DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant SMITH & NEPHEW, INC. 3600 NW 138TH ST. Oklahoma City,  OK  73134
ContactSteven Jackson
CorrespondentSteven Jackson
SMITH & NEPHEW, INC. 3600 NW 138TH ST. Oklahoma City,  OK  73134
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-13
Decision Date2002-10-03
Summary:summary

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