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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K954747
Device Name NIOMED BARRIER GOWNS
Applicant
Amerasia Corp.
4121 Tigris Way
Riverside,  CA  92503
Applicant Contact DAVID SONG
Correspondent
Amerasia Corp.
4121 Tigris Way
Riverside,  CA  92503
Correspondent Contact DAVID SONG
Regulation Number878.4040
Classification Product Code
FYC  
Date Received10/16/1995
Decision Date 03/06/1996
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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