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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 K020399
FOIA Releasable 510(k) K020399
Device Name RESPERATE; MODEL RR-150
Applicant
Intercure , Ltd.
555 13th St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Intercure , Ltd.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received02/06/2002
Decision Date 07/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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