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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K242964
Device Name Celsi Warmer
Applicant
Hadleigh Health Technologies
200 Gate Five Rd. Suite 215
Sausalito,  CA  94965
Applicant Contact Molly McCabe
Correspondent
RQM+
2790 Mosside Blvd., Suite 800
Monroeville,,  PA  15146
Correspondent Contact Dulciana Chan
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/26/2024
Decision Date 06/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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