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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 K032878
Device Name KUNG SHIN, HMEF SK203
Applicant
Kung Shin Plastics Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
Kung Shin Plastics Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/15/2003
Decision Date 09/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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