PENCAN SPINAL NEEDLE

Needle, Conduction, Anesthetic (w/wo Introducer)

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Pencan Spinal Needle.

Pre-market Notification Details

Device IDK112515
510k NumberK112515
Device Name:PENCAN SPINAL NEEDLE
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactLisa Giaquinto
CorrespondentLisa Giaquinto
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-30
Decision Date2011-12-22
Summary:summary

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