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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K973107
Device Name AMSINO I.V. ADMINISTRATION SET
Applicant
Amsino Intl., Inc.
833 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact RICHARD Y LI
Correspondent
Amsino Intl., Inc.
833 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact RICHARD Y LI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/19/1997
Decision Date 10/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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