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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K202987
Device Name Rescue Pulmonary Grasping Forceps
Applicant
Anrei Medical (Hangzhou) Co., Ltd
No. 3 Ave 8, HEDA
Hangzhou,  CN 310018
Applicant Contact Huibing Yang
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Jia Huang
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/30/2020
Decision Date 04/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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