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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 K200321
Device Name Novaerus NV1050
Applicant
Novaerus US Inc
35 Melrose Place
Stamford,  CT  06902
Applicant Contact Declan Kiely
Correspondent
Novaerus US Inc
35 Melrose Place
Stamford,  CT  06902
Correspondent Contact Declan Kiely
Regulation Number880.5045
Classification Product Code
FRF  
Date Received02/10/2020
Decision Date 12/28/2020
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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