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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 K014210
Device Name PALMO THERMOREGULATION INTERFACE ACCESSORY
Applicant
AVACORE TECHNOLOGIES, INC.
251 HIGH STREET, SUITE B
PALO ALTO,  CA  94301
Applicant Contact CRAIG COOMBS
Correspondent
AVACORE TECHNOLOGIES, INC.
251 HIGH STREET, SUITE B
PALO ALTO,  CA  94301
Correspondent Contact CRAIG COOMBS
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received12/21/2001
Decision Date 08/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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