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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 K882304
Device Name DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
Applicant
ABCO DEALERS, INC.
6601 W. MILL RD.
P.O. BOX 23090
MILWAUKEE,  WI  53218 -1238
Applicant Contact MOLLY PETR
Correspondent
ABCO DEALERS, INC.
6601 W. MILL RD.
P.O. BOX 23090
MILWAUKEE,  WI  53218 -1238
Correspondent Contact MOLLY PETR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/03/1988
Decision Date 07/12/1988
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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