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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 K051177
Device Name PVC AND SILICONE MANUAL RESUSCITATORS
Applicant
David Medical Products Co.,Ltd
88 Fuda Rd. Ludu
Taicang,Suzhou,Jiangsu,  CN 215412
Applicant Contact DAVID LU
Correspondent
David Medical Products Co.,Ltd
88 Fuda Rd. Ludu
Taicang,Suzhou,Jiangsu,  CN 215412
Correspondent Contact DAVID LU
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/06/2005
Decision Date 08/29/2005
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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