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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 K212824
Device Name Bluezone Model RX-450 Air Purifier
Applicant
Bluezone Products, Inc.
225 Wildwood Ave.
Woburn,  MA  01801
Applicant Contact Karen Benedek
Correspondent
O'Connell Regulatory Consultant, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number880.6500
Classification Product Code
FRA  
Date Received09/03/2021
Decision Date 02/17/2022
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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