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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 K062313
Device Name SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
Applicant
Pt Mahakarya Inti Buana
J1. Sei Belumai
Desa Dalu 10 A Dusun I
Tanjung Morawa, Sumut,  ID 20362
Applicant Contact VENUGOPAL NADARAJAN
Correspondent
Pt Mahakarya Inti Buana
J1. Sei Belumai
Desa Dalu 10 A Dusun I
Tanjung Morawa, Sumut,  ID 20362
Correspondent Contact VENUGOPAL NADARAJAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/08/2006
Decision Date 11/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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