BUSSE EPIDURAL CATHETER KIT

Catheter, Conduction, Anesthetic

BUSSE HOSPITAL DISPOSABLES

The following data is part of a premarket notification filed by Busse Hospital Disposables with the FDA for Busse Epidural Catheter Kit.

Pre-market Notification Details

Device IDK093920
510k NumberK093920
Device Name:BUSSE EPIDURAL CATHETER KIT
ClassificationCatheter, Conduction, Anesthetic
Applicant BUSSE HOSPITAL DISPOSABLES 75 ARKAY DRIVE Hauppauge,  NY  11788
ContactMuhamad Ansari
CorrespondentMuhamad Ansari
BUSSE HOSPITAL DISPOSABLES 75 ARKAY DRIVE Hauppauge,  NY  11788
Product CodeBSO  
CFR Regulation Number868.5120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-22
Decision Date2010-08-06
Summary:summary

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