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510(k) K253068

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe by CMT Health PTE., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2026
Date Received
September 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by CMT Health PTE., Ltd.

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  • K251585 — Profoject™ Enteral Feeding Syringe (July 18, 2025)

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