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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K231558
Device Name SMB Luer lock disposable syringe
Applicant
Smb Corporation of India
Plot # 156 Gidc Umbergaon
Valsad,  IN 396170
Applicant Contact Anupam Rai
Correspondent
Alceon Medtech Consulting
1008, 10th Floor, “Ocean”, Sarabhai Compound
Near Centre Sq. Mall, Dr. V.S. Marg
Vadodara,  IN 390023
Correspondent Contact Atonu Datta
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received05/30/2023
Decision Date 01/12/2024
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
Predetermined Change
Control Plan Authorized		 No
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