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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K231724
Device Name Flush Syringe (Prefilled 0.9% normal saline solution)
Applicant
Spm Medicare Pvt. , Ltd.
B-40, Phase Ii
Gautam Budh Nagar,  IN 201305
Applicant Contact Sanjay Kumar
Correspondent
Spm Medicare Pvt. , Ltd.
B-40, Phase Ii
Gautam Budh Nagar,  IN 201305
Correspondent Contact Sanjay Kumar
Regulation Number880.5200
Classification Product Code
NGT  
Date Received06/13/2023
Decision Date 11/09/2023
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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