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510(k) K221540

Synexis Sphere Rx by Synexis, LLC — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2023
Date Received
May 27, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Air, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6500
Review Panel
HO
Submission Type

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