VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE

Endoscope, Flexible

VAN-TEC, INC.

The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Van-tec Disposable Flexible Endoscope.

Pre-market Notification Details

Device IDK860771
510k NumberK860771
Device Name:VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE
ClassificationEndoscope, Flexible
Applicant VAN-TEC, INC. P.O. BOX 26 Spencer,  IN  47460
ContactJames F Vance
CorrespondentJames F Vance
VAN-TEC, INC. P.O. BOX 26 Spencer,  IN  47460
Product CodeGCQ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-03
Decision Date1986-04-23

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