RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles

Needle, Conduction, Anesthetic (w/wo Introducer)

MYCO Medical Supplies, Inc.

The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Reli Nrfit Epidural Needles, Phoenix Nrfit Epidural Needles, Reli Nrfit Spinal Needles, Phoenix Nrfit Spinal Needles.

Pre-market Notification Details

Device IDK203668
510k NumberK203668
Device Name:RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant MYCO Medical Supplies, Inc. 2015 Production Drive Apex,  NC  27539
ContactSanjiv Krumar
CorrespondentE.j. Smith
Smith Associates 1468 Harwell Ave. Crofton,  MD  21114
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-16
Decision Date2021-09-29

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.