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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K940797
Device Name SIME SURGICAL LATEX GLOVE
Applicant
Sime Health, Ltd.
1200 Sixth Ave. S.
Seattle,  WA  98134
Applicant Contact MEI L CHUA
Correspondent
Sime Health, Ltd.
1200 Sixth Ave. S.
Seattle,  WA  98134
Correspondent Contact MEI L CHUA
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/22/1994
Decision Date 05/09/1994
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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