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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 K897047
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
P.T. Gotong Rojong Djaja
Jl. Hindu # 33
Medan 20111
Indonesia,  ID
Applicant Contact FACHRY HASBALLAH
Correspondent
P.T. Gotong Rojong Djaja
Jl. Hindu # 33
Medan 20111
Indonesia,  ID
Correspondent Contact FACHRY HASBALLAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/18/1989
Decision Date 01/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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