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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 K200751
Device Name Photodynamic Therapy (PDT) Equipment
Applicant
Shangdong Huamei Technology Co., Ltd.
No. 588, Changning Street, High-tech District
Weifang,  CN 261205
Applicant Contact Xu QingHua
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONF  
Date Received03/23/2020
Decision Date 05/21/2020
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
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