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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. N.W.
washington,  DC  20004 -1109
Applicant Contact jonathan s kahan
Correspondent
INTERCURE LTD.
555 13TH ST. N.W.
washington,  DC  20004 -1109
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
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