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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K973199
Device Name AMSINO SUCTION CATHETER
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 Number868.6810
Classification Product Code
BSY  
Date Received08/26/1997
Decision Date 09/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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