EPIDURAL ANESTHESIA NEEDLES

Needle, Conduction, Anesthetic (w/wo Introducer)

REGANES, INC.

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

Pre-market Notification Details

Device IDK854816
510k NumberK854816
Device Name:EPIDURAL ANESTHESIA NEEDLES
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant REGANES, INC. P.O. BOX 13212 Clearwater,  FL  33519
ContactJoseph E Harms
CorrespondentJoseph E Harms
REGANES, INC. P.O. BOX 13212 Clearwater,  FL  33519
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-03
Decision Date1985-12-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20809160324353 K854816 000
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M661S885183501 K854816 000
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20809160323493 K854816 000
20809160323486 K854816 000
40193489902823 K854816 000
M661S075173501 K854816 000

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