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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K213256
Device Name ThermoTK
Applicant
Zimmer Medizinsysteme GmbH
Junkersstrasse 9
Neu-Elm,  DE 89231
Applicant Contact Ute Hauss
Correspondent
Quality and Regulatory Services
151 Gleasondale Rd.
Stow,  MA  01775
Correspondent Contact Scott Blood
Regulation Number878.4400
Classification Product Code
PBX  
Date Received09/30/2021
Decision Date 05/25/2023
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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