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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 K892317
Device Name VINYL EXAM GLOVES (MFG. TSE FONG)
Applicant
Svenska Medita Ac.
C/O Lowenkamp Int'L Inc.
P.O. Box 878
Hazlehurst,  MS  39083
Applicant Contact WILLIAM LOWENKAMP,JR
Correspondent
Svenska Medita Ac.
C/O Lowenkamp Int'L Inc.
P.O. Box 878
Hazlehurst,  MS  39083
Correspondent Contact WILLIAM LOWENKAMP,JR
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/06/1989
Decision Date 08/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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