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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 K080763
Device Name TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT
Applicant
TALLEY MEDICAL
1070 E. WIELAND RD.
LANSING,  MI  48906
Applicant Contact JACK VAN DYKE
Correspondent
TALLEY MEDICAL
1070 E. WIELAND RD.
LANSING,  MI  48906
Correspondent Contact JACK VAN DYKE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received03/18/2008
Decision Date 05/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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