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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name latex patient examination glove
510(k) Number K894972
Device Name UNICARE LATEX EXAMINATION GLOVES
Original Applicant
PT. INDORUB NUSARAYA
jl. semarang no. 105/16
medan, sumatera utara,  ID 20212
Original Contact santoso lutan
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/07/1989
Decision Date 09/12/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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