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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
Applicant
Global Medikit Limited
Khasra No 323 MI, Camp Road, Selaqui,
Dehradun,  IN 248197
Applicant Contact Karun Narang
Correspondent
Alceon
201-203 Tilak Complex, Jetalpur Road
Vadodara,  IN 390007
Correspondent Contact Atonu Dutta
Regulation Number868.5150
Classification Product Code
BSP  
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
Predetermined Change
Control Plan Authorized		 No
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