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510(k) K232950

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle by Perfect Medical Industry (Vn) Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2024
Date Received
September 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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