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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 K902696
Device Name N-DEX
Applicant
Moss Point Glove Co.
4219 Jefferson Ave.
P.O. Box 569
Moss Point,  MS  39563
Applicant Contact LUC DEBECKER
Correspondent
Moss Point Glove Co.
4219 Jefferson Ave.
P.O. Box 569
Moss Point,  MS  39563
Correspondent Contact LUC DEBECKER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/19/1990
Decision Date 09/05/1990
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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