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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 K953955
Device Name POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
Applicant
Codan Medlon, Inc.
22 Dogwood Dr.
Chester,  NJ  07930
Applicant Contact MURIEL G WILLICH
Correspondent
Codan Medlon, Inc.
22 Dogwood Dr.
Chester,  NJ  07930
Correspondent Contact MURIEL G WILLICH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/15/1995
Decision Date 08/20/1996
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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