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510(k) Data Aggregation
K Number
K243149Device Name
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
Manufacturer
Congruence Medical Solutions, LLC
Date Cleared
2024-12-20
(81 days)
Product Code
QLY, FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Congruence Medical Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body. The Microliter Dosing Syringe is indicated for intravitreal use.
Device Description
The Microliter Dosing Syringe is a single-use, piston syringe-based device consisting of a syringe barrel, plunger stopper, syringe tip cap and incorporates a plunger rod subassembly. It is intended for use by healthcare professionals for general purpose fluid aspiration/injection. Its operation is manual. The Microliter Dosing Syringe is single use only, non-toxic, non-pyrogenic and sterilized by e-beam irradiation. The Microliter Dosing Syringe is suitable for ophthalmic use.
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