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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 K890149
Device Name SURGIMAX (LATEX EXAM GLOVES)
Applicant
National Dental Supply, Inc.
204 Progress Dr.
Montgomeryville,  PA  18936
Applicant Contact KIRIT PATEL
Correspondent
National Dental Supply, Inc.
204 Progress Dr.
Montgomeryville,  PA  18936
Correspondent Contact KIRIT PATEL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/13/1989
Decision Date 03/22/1989
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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