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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Patient
510(k) Number K911921
Device Name DISPOSABLE ISOLATION GOWN
Applicant
Liaoning-Usa Corp.
123 W. Bellevue, Unit#4
Pasadena,  CA  91105
Applicant Contact JAY A BROWN
Correspondent
Liaoning-Usa Corp.
123 W. Bellevue, Unit#4
Pasadena,  CA  91105
Correspondent Contact JAY A BROWN
Regulation Number878.4040
Classification Product Code
FYB  
Date Received04/30/1991
Decision Date 05/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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