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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 K233794
Device Name Insulin Syringe
Applicant
SPM Medicare Pvt. Ltd.
B-40, Phase II
Gautam Budh Nagar
Noida,  IN 201305
Applicant Contact Vipin Panwar
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/28/2023
Decision Date 03/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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