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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 K890776
Device Name LANGS EXAM GLOVE
Applicant
LANGS INTL., INC.
UNIT 11, 110 MIDDLESEX ST.
NORTH CHELMSFORD,  MA  01863
Applicant Contact CHEN
Correspondent
LANGS INTL., INC.
UNIT 11, 110 MIDDLESEX ST.
NORTH CHELMSFORD,  MA  01863
Correspondent Contact CHEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/15/1989
Decision Date 05/12/1989
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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