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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty
510(k) Number K172717
Device Name Automatic Tissue Processing Unit
Applicant
Bsl Co.
6-13, Chilsan-Ro 237 Beon-Gil
Gimhae-Si,  KR 51006
Applicant Contact Jun Suk Lee
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number878.5040
Classification Product Code
MUU  
Date Received09/08/2017
Decision Date 05/25/2018
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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