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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K171648
Device Name BM.IRIS
Applicant
Bluecore Co., Ltd.
Acehigh 21, 48 Centum-Jungang Ro 128
Haeundae-Gu,  KR
Applicant Contact Bill Choi
Correspondent
Bio-Med USA, Inc.
111 Ellison St.
Paterson,  NJ  07446
Correspondent Contact Young Chi
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/05/2017
Decision Date 09/08/2017
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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