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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K151498
Device Name Breathing circuit bacterial/viral filter
Applicant
Zhejiang Haisheng Medical Device Co., Ltd.
305#Tanggong Rd., Paojiang Industrial Zone
Shaoxing,  CN 312071
Applicant Contact HU JUBIN
Correspondent
Medwheat (Shanghai) Medical Technology Co. , Ltd.
Yangpu Distrist Liaoyuan E. Rd. Shuangyang
First Suite #33 Rm. 303
Shanghai,  CN 200093
Correspondent Contact JONATHAN HU
Regulation Number868.5260
Classification Product Code
CAH  
Date Received06/04/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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