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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K171961
Device Name Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
Applicant
Xiamen Compower Medical Tech. Co., Ltd.
Unit 301, #16 Xianghong Rd., Xiang'An Torch
Industrial Zone
Xiamen,  CN 361101
Applicant Contact Lifen Chen
Correspondent
Namsa
400 Hwy. 169 S.
Suite 500
Minneapolis,  MN  55426
Correspondent Contact Lynn Jensen
Regulation Number868.5870
Classification Product Code
CBP  
Date Received06/30/2017
Decision Date 11/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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