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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K050654
Device Name AMSINO I.V. START KIT
Applicant
Amsino International, Inc.
855 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact CHING CHING SEAH
Correspondent
Amsino International, Inc.
855 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact CHING CHING SEAH
Regulation Number880.5200
Classification Product Code
LRS  
Date Received03/14/2005
Decision Date 05/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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