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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 K211931
Device Name Medline Digital Thermometer Non-Lubricated Probe Sheath
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Kelsey Closen
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Kelsey Closen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/22/2021
Decision Date 09/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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