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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 K040911
FOIA Releasable 510(k) K040911
Device Name VITALHEAT
Applicant
Dynatherm Medical, Inc.
819 Mitten Rd., Suite 42
Burlingame,  CA  94010
Applicant Contact JOHN R KANE
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact DENISE LEUNG KLINKER
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received04/08/2004
Decision Date 06/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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