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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 K181095
Device Name RF-Relief
Applicant
El Global Trade, Ltd.
8 Tzoran St., P.O.Box 8242
Netanya,  IL 4250608
Applicant Contact Martin Gurovich
Correspondent
El Global Trade, Ltd.
8 Tzoran St., P.O.Box 8242
Netanya,  IL 4250608
Correspondent Contact Martin Gurovich
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
GEI  
Date Received04/26/2018
Decision Date 07/24/2018
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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