Medispine - Spinal Needle, Glospine - Spinal Needle

Needle, Conduction, Anesthetic (w/wo Introducer)

Global Medikit Limited

The following data is part of a premarket notification filed by Global Medikit Limited with the FDA for Medispine - Spinal Needle, Glospine - Spinal Needle.

Pre-market Notification Details

Device IDK212982
510k NumberK212982
Device Name:Medispine - Spinal Needle, Glospine - Spinal Needle
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant Global Medikit Limited Khasra No 323 MI, Camp Road, Selaqui, Dehradun,  IN 248197
ContactKarun Narang
CorrespondentAtonu Dutta
Alceon 201-203 Tilak Complex, Jetalpur Road Vadodara,  IN 390007
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-17
Decision Date2022-07-29

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