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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 K170871
Device Name DigniCap Scalp Cooling System
Applicant
Dignitana AB
Traktorgranden 3
Lund,  SE se-226 60
Applicant Contact Johan Ericsson
Correspondent
Experien Group, LLC
224 Airport Pkwy.
San Jose,  CA  95110
Correspondent Contact Michael J. Billig
Regulation Number878.4360
Classification Product Code
PMC  
Date Received03/23/2017
Decision Date 07/03/2017
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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