SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE

Endoilluminator

SYNERGETICS, INC.

The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Synergetics Synerlight Fiber Optic Lightsource.

Pre-market Notification Details

Device IDK964005
510k NumberK964005
Device Name:SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
ClassificationEndoilluminator
Applicant SYNERGETICS, INC. 15 FOXHUNT DR. Chesterfield,  MO  63017
ContactJames Taylor
CorrespondentJames Taylor
SYNERGETICS, INC. 15 FOXHUNT DR. Chesterfield,  MO  63017
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-07
Decision Date1997-06-09
Summary:summary

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