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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 K910542
Device Name DIGIFLEX, LATEX PATIENT EXAMINATION GLOVES
Applicant
21ST CENTURY GROUP
15 BARDWELL ST., SUITE 3
BOSTON,  MA  02130
Applicant Contact MICHAEL C CONROY
Correspondent
21ST CENTURY GROUP
15 BARDWELL ST., SUITE 3
BOSTON,  MA  02130
Correspondent Contact MICHAEL C CONROY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/05/1991
Decision Date 02/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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