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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name patient examination glove
510(k) Number K821028
Device Name FINGER COTS
Applicant
ABCO DEALERS, INC.
WI 
Correspondent
ABCO DEALERS, INC.
WI 
Regulation Number880.6250
Classification Product Code
FMC  
Date Received04/13/1982
Decision Date 04/26/1982
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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