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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Syringe
510(k) Number K243149
Device Name Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
Applicant
Congruence Medical Solutions, LLC
3000 Falls Rd.
Suite 200a
Baltimore,  MD  21211
Applicant Contact Gautam Shetty
Correspondent
Congruence Medical Solutions, LLC
3000 Falls Rd.
Suite 200a
Baltimore,  MD  21211
Correspondent Contact Gautam Shetty
Regulation Number880.5860
Classification Product Code
QLY  
Subsequent Product Code
FMF  
Date Received09/30/2024
Decision Date 12/20/2024
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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