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510(k) K231519

Revital Cady by Revital Healthcare (Epz) Limited — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2023
Date Received
May 25, 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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