STRYKER INFRAVISION ESOPHAGEAL KIT

Bougie, Esophageal, And Gastrointestinal, Gastro-urology

Stryker Endoscopy

The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Infravision Esophageal Kit.

Pre-market Notification Details

Device IDK983220
510k NumberK983220
Device Name:STRYKER INFRAVISION ESOPHAGEAL KIT
ClassificationBougie, Esophageal, And Gastrointestinal, Gastro-urology
Applicant Stryker Endoscopy 2590 WALSH AVE. Santa Clara,  CA  95051 -4085
ContactSean Cahill
CorrespondentSean Cahill
Stryker Endoscopy 2590 WALSH AVE. Santa Clara,  CA  95051 -4085
Product CodeFAT  
CFR Regulation Number876.5365 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-14
Decision Date1999-06-04
Summary:summary

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