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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 K000405
Device Name INTERCURE LTD. RESPI-LOW
Applicant
Intercure , Ltd.
555 13th St., NW
Washington,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
Intercure , Ltd.
555 13th St., NW
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received02/07/2000
Decision Date 05/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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