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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 K042556
Device Name SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
Applicant
ENTER MEDICAL CORPORATION
NO.16-1, LANE 564
WEN HUA SAN ROAD
GUI SHAN XIANG,TAO YUAN HSIEN,  TW 333
Applicant Contact TZONG-FUH KUO
Correspondent
ENTER MEDICAL CORPORATION
NO.16-1, LANE 564
WEN HUA SAN ROAD
GUI SHAN XIANG,TAO YUAN HSIEN,  TW 333
Correspondent Contact TZONG-FUH KUO
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/20/2004
Decision Date 03/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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