Remington Medical Inc. Tuohy Epidural Needles

Needle, Conduction, Anesthetic (w/wo Introducer)

REMINGTON MEDICAL, INC.

The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical Inc. Tuohy Epidural Needles.

Pre-market Notification Details

Device IDK150266
510k NumberK150266
Device Name:Remington Medical Inc. Tuohy Epidural Needles
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT Alpharetta,  GA  30005
ContactCaitlin Senter
CorrespondentCaitlin Senter
REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT Alpharetta,  GA  30005
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-04
Decision Date2015-06-04
Summary:summary

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