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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 K896399
Device Name WHITE MAGNOLIA DENUDATE LATEX EXAMINATION GLOVES
Applicant
Prime Horizon, Inc.
147 Timber Hill Dr.
P.O. Box 43
East Hanover,  NJ  07936
Applicant Contact YEH NAN
Correspondent
Prime Horizon, Inc.
147 Timber Hill Dr.
P.O. Box 43
East Hanover,  NJ  07936
Correspondent Contact YEH NAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/07/1989
Decision Date 12/11/1989
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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