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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 K910439
Device Name FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM)
Applicant
Lowenkamp Intl., Inc.
P.O. Box 878
Hazlehurst,  MS  39083
Applicant Contact WILLIAM LOWENKAMP,JR
Correspondent
Lowenkamp Intl., Inc.
P.O. Box 878
Hazlehurst,  MS  39083
Correspondent Contact WILLIAM LOWENKAMP,JR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/31/1991
Decision Date 02/25/1991
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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