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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K220298
Device Name CerroZone Mobile
Applicant
CerroZone
P.O.Box 66800
St. Louis,  MO  63166
Applicant Contact Marlon E. Robinson
Correspondent
RQM+
2251 San Diego Avenue, Ste B-257
San Diego,  CA  92110
Correspondent Contact Matthieu Kirkland
Regulation Number880.5045
Classification Product Code
FRF  
Date Received02/02/2022
Decision Date 07/01/2022
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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