ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY

Needle, Conduction, Anesthetic (w/wo Introducer)

B. BRAUN OF AMERICA, INC.

The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Espocan Combined Spinal/epidural Needle Set & Tray.

Pre-market Notification Details

Device IDK932400
510k NumberK932400
Device Name:ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem,  PA  18018 -0027
ContactChristine M Harris
CorrespondentChristine M Harris
B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem,  PA  18018 -0027
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-18
Decision Date1993-12-13

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