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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K193158
Device Name ACENT™ Central Venous Catheter
Applicant
Global Medikit Limited
Khasra No 323 MI, Camp Road, Selaqui,
Dehradun,  IN 248197
Applicant Contact Mahendra Singh
Correspondent
Meditech Consulting
102, Platinum Avenue, Vikram Society, Gotri Road
Vadodara,  IN 390021
Correspondent Contact Atonu Dutta
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/14/2019
Decision Date 11/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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