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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K231437
Device Name LF900
Applicant
Daesung Maref Co., Ltd
298-24, Gongdan-ro
Gunpo-Si,  KR 15809
Applicant Contact Su Hyeon So
Correspondent
Daesung Maref Co., Ltd
298-24, Gongdan-ro
Gunpo-Si,  KR 15809
Correspondent Contact Su Hyeon So
Regulation Number890.5650
Classification Product Code
IRP  
Date Received05/17/2023
Decision Date 07/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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