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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 K211526
Device Name Portable Scalp Cooling System
Applicant
Cooler Heads Care, Inc.
2801 B St., #209
San Diego,  CA  92102
Applicant Contact Kate Dilligan
Correspondent
Acknowledge Regulatory Strategies
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Pierre Bounaud
Regulation Number878.4360
Classification Product Code
PMC  
Date Received05/17/2021
Decision Date 10/21/2021
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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