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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K191425
Device Name Hydro-Temp Neonatal Skin Temperature Probe Cover
Applicant
Deroyal Industries, Inc.
200 Debusk Lane
Powell,  TN  37849
Applicant Contact Sarah Bennett
Correspondent
Deroyal Industries, Inc.
200 Debusk Lane
Powell,  TN  37849
Correspondent Contact Sarah Bennett
Regulation Number880.5130
Classification Product Code
FMT  
Date Received05/29/2019
Decision Date 01/21/2020
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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