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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K221540
Device Name Synexis Sphere Rx
Applicant
Synexis, LLC
11711 W. 79th St.
Lenexa,  KS  66214
Applicant Contact Athena Hansen
Correspondent
Synexis, LLC
11711 W. 79th St.
Lenexa,  KS  66214
Correspondent Contact Laura LeBoeuf
Regulation Number880.6500
Classification Product Code
FRA  
Date Received05/27/2022
Decision Date 06/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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