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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Accessory Microbial Reduction Device.
510(k) Number K243815
Device Name SoClean 3+
Applicant
Soclean, Inc.
1 Vose Farm Rd.
Peterborough,  NH  03458
Applicant Contact George Peters
Correspondent
Hogan Lovells US LLP
Columbia Square
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Classification Product Code
QXQ  
Date Received12/11/2024
Decision Date 10/10/2025
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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