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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K780593
Device Name PROBE COVER
Applicant
Abco Dealers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Abco Dealers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/10/1978
Decision Date 06/06/1978
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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