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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Footrest, Wheelchair
510(k) Number K892791
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
UNION INDUSTRIAL CO., LTD.
45 MU 2 SOI THAI AREE,
SUKSAWAD ROAD
BANGKRUT PHA SMUTPAR,  TH
Applicant Contact ANDREW KWOK
Correspondent
UNION INDUSTRIAL CO., LTD.
45 MU 2 SOI THAI AREE,
SUKSAWAD ROAD
BANGKRUT PHA SMUTPAR,  TH
Correspondent Contact ANDREW KWOK
Regulation Number890.3920
Classification Product Code
IMM  
Date Received04/11/1989
Decision Date 08/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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