UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle

Needle, Conduction, Anesthetic (w/wo Introducer)

UNISIS CORP.

The following data is part of a premarket notification filed by Unisis Corp. with the FDA for Uniever Disposable Epidural Anesthesia Needle, Uniever Disposable Nerve Blocked Needle.

Pre-market Notification Details

Device IDK142553
510k NumberK142553
Device Name:UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant UNISIS CORP. 2675-1, NISHIKATA Koshigaya-shi,  JP 3430822
ContactTadashi Yasuda
CorrespondentDiane Rutherford
KEN BLOCK CONSULTING 1201 RICHARDSON DRIVE SUITE 280 Richardson,  TX  75080 -4403
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-10
Decision Date2015-01-14
Summary:summary

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