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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Surgical
510(k) Number K954454
Device Name NIOMED SURGICAL HOOD
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
FYF  
Date Received09/25/1995
Decision Date 01/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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