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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K021716
Device Name SIMPLIFY COMPACT RESUSCITATOR
Applicant
Polymed (Xiamen) Plastic Industrial Co., Ltd.
Unit B,1-5 F,Warehouse & Proc.
Complex Bldg. Xiangyu F.T.Z.
Xiamen,  CN
Applicant Contact SHAN HUA YING
Correspondent
Polymed (Xiamen) Plastic Industrial Co., Ltd.
Unit B,1-5 F,Warehouse & Proc.
Complex Bldg. Xiangyu F.T.Z.
Xiamen,  CN
Correspondent Contact SHAN HUA YING
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/23/2002
Decision Date 10/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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