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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K002745
Device Name VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
Applicant
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
128 JALAN KYAI HAJI MUHAMMAD
MANSYUR
JAKARTA BARAT,  ID 11210
Applicant Contact LINGA SUMARTA
Correspondent
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
128 JALAN KYAI HAJI MUHAMMAD
MANSYUR
JAKARTA BARAT,  ID 11210
Correspondent Contact LINGA SUMARTA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/05/2000
Decision Date 10/12/2000
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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