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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K913016
Device Name WARMTOUCH
Applicant
Advanced Warming Systems, Inc.
3414 22nd. St.
Lubbock,  TX  79410
Applicant Contact PATRICK J GRIFFIN
Correspondent
Advanced Warming Systems, Inc.
3414 22nd. St.
Lubbock,  TX  79410
Correspondent Contact PATRICK J GRIFFIN
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received07/01/1991
Decision Date 09/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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