FDA 510(k) Application Details - K192468

Device Classification Name Catheter, Urethral

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510(K) Number K192468
Device Name Catheter, Urethral
Applicant Hangzhou Bever Medical Devices Co., Ltd.
Building 2, No. 1-1, Houmuqiao, Yongle Village,
Cangqian St., Yuhang Dist.
Hangzhou 311121 CN
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Contact Allyson Zhou
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Regulation Number 876.5130

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Classification Product Code GBM
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Date Received 09/09/2019
Decision Date 11/27/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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