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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 K173032
Device Name Paxman Scalp Cooler
Applicant
Paxman Coolers Limited
International House, Penistone Rd., Fenay Bridge
Huddersfield,  GB HD8 0LE
Applicant Contact Richard Paxman
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Builiding 1, Suite 300
Austin,  TX  78746
Correspondent Contact Heather Crawford
Regulation Number878.4360
Classification Product Code
PMC  
Date Received09/28/2017
Decision Date 06/07/2018
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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