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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K023276
Device Name AMSINO TRACHEOSTOMY CARE TRAY
Applicant
Amsino International, Inc.
4501 Brickell Privado St.
Ontario,  CA  91761
Applicant Contact DEAN R GAUF
Correspondent
Amsino International, Inc.
4501 Brickell Privado St.
Ontario,  CA  91761
Correspondent Contact DEAN R GAUF
Regulation Number878.4370
Classification Product Code
LRO  
Subsequent Product Code
KDD  
Date Received10/01/2002
Decision Date 12/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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