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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K971929
Device Name AMSINO URINARY LEG BAG
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 Number876.5250
Classification Product Code
KNX  
Subsequent Product Code
FAQ  
Date Received05/27/1997
Decision Date 08/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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