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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
Predetermined Change
Control Plan Authorized		 No
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