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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 K892610
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
PT. INDOLEX KARYA PRAKARSA
JLN. JEMBATAN TIGA
PLUIT MAS BLOK BB 7-8
JAKARTA 14450, INDONESIA,  ID
Applicant Contact ALEXANDER
Correspondent
PT. INDOLEX KARYA PRAKARSA
JLN. JEMBATAN TIGA
PLUIT MAS BLOK BB 7-8
JAKARTA 14450, INDONESIA,  ID
Correspondent Contact ALEXANDER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 09/18/1989
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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