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510(k) K213560

Verifine Safety Syringe with Fixed Needle by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2022
Date Received
November 9, 2021
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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