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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Blood, Non-Electromagnetic Radiation
510(k) Number K012031
Device Name MODIFICATION TO THERMAL ANGEL
Applicant
Estill Medical Technologies, Inc.
4144 N. Central Expy.
Suite 260
Dallas,  TX  75204
Applicant Contact DANIEL T KISTNER
Correspondent
Estill Medical Technologies, Inc.
4144 N. Central Expy.
Suite 260
Dallas,  TX  75204
Correspondent Contact DANIEL T KISTNER
Regulation Number864.9205
Classification Product Code
BSB  
Subsequent Product Code
LGZ  
Date Received06/28/2001
Decision Date 07/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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