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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K131586
Device Name CANCARY BREATHING SYSTEM
Applicant
PALO ALTO HEALTH SCIENCES, INC.
755 N MATHILDA AVE
SUITE 100
SUNNYVALE,  CA  94085
Applicant Contact LORI ADELS, PHD
Correspondent
PALO ALTO HEALTH SCIENCES, INC.
755 N MATHILDA AVE
SUITE 100
SUNNYVALE,  CA  94085
Correspondent Contact LORI ADELS, PHD
Regulation Number882.5050
Classification Product Code
HCC  
Subsequent Product Code
CCK  
Date Received05/31/2013
Decision Date 12/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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