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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K864158
Device Name THERMAPAD
Applicant
Avail-Southwest Division
4201 B Kellway Cir.
Dallas,  TX  75244
Applicant Contact KEN W KNEZEK
Correspondent
Avail-Southwest Division
4201 B Kellway Cir.
Dallas,  TX  75244
Correspondent Contact KEN W KNEZEK
Regulation Number880.6060
Classification Product Code
KME  
Date Received10/23/1986
Decision Date 03/02/1987
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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