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510(k) K232593

FITme Customized Silicone Implant by Keosan Trading Co. — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2023
Date Received
August 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Keosan Trading Co.

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