Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-