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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K212982
Device Name Medispine - Spinal Needle, Glospine - Spinal Needle
Global Medikit Limited
Khasra No 323 MI, Camp Road, Selaqui,
Dehradun,  IN 248197
Applicant Contact Karun Narang
201-203 Tilak Complex, Jetalpur Road
Vadodara,  IN 390007
Correspondent Contact Atonu Dutta
Regulation Number868.5150
Classification Product Code
Date Received09/17/2021
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No