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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K952897
Device Name NIOMED SHOE COVERS
Applicant
Amerasia Corp.
14228 Mac Devitt St.
Baldwin Park,  CA  91706
Applicant Contact DAVID SONG
Correspondent
Amerasia Corp.
14228 Mac Devitt St.
Baldwin Park,  CA  91706
Correspondent Contact DAVID SONG
Regulation Number878.4040
Classification Product Code
FXP  
Date Received06/23/1995
Decision Date 10/23/1995
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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