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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scalp Cooling System
510(k) Number K252289
Device Name Eva Scalp Cooling System
Applicant
Stemtech Medical Devices Private Limited
411, 4th Floor, Tesla Industrial Bldg. No-1 Tesla
Plot No Gen-2/1/C (Part), Trans Thane Creek Industrial Area
Navi Mumbai,  IN 400706
Applicant Contact Subrai Pai
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Regulation Number878.4360
Classification Product Code
PMC  
Date Received07/23/2025
Decision Date 11/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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