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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 K912999
Device Name DENTA SAFE(TM) LATEX EXAMINATION GLOVES
Applicant
DENTAL CARE INTL., INC.
14134 NEPHRON LN.
HUDSON,  FL  34667
Applicant Contact ACHARYA
Correspondent
DENTAL CARE INTL., INC.
14134 NEPHRON LN.
HUDSON,  FL  34667
Correspondent Contact ACHARYA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/08/1991
Decision Date 08/13/1991
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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