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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K871465
Device Name THERMOMETER SHEATHS
Applicant
ABCO DEALERS, INC.
6601 W. MILL RD.
P.O. BOX 23090
MILWAUKEE,  WI  53218 -1238
Applicant Contact MOLLY PRIBEK
Correspondent
ABCO DEALERS, INC.
6601 W. MILL RD.
P.O. BOX 23090
MILWAUKEE,  WI  53218 -1238
Correspondent Contact MOLLY PRIBEK
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/14/1987
Decision Date 05/11/1987
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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