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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dental barriers and sleeves
510(k) Number K190484
Device Name BH Medical Dental Barrier Sleeves and Barrier Film
Applicant
BH Medical Products Co., Ltd.
No.90 Shenjiang Villagers' group, Zhangjiacunwei, Xilin
Street, Zhonglou District
Changzhou,  CN 213024
Applicant Contact Xiaohua TAO
Correspondent
BH Medical Products Co., Ltd.
No.90 Shenjiang Villagers' group, Zhangjiacunwei, Xilin
Street, Zhonglou District
Changzhou,  CN 213024
Correspondent Contact Xiaohua TAO
Regulation Number878.4370
Classification Product Code
PEM  
Date Received02/27/2019
Decision Date 09/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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