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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K864569
Device Name PODODIGITAL
Applicant
Broadwest Corp.
260 W. Broadway
New York,  NY  10013
Applicant Contact JACK DONOVAN
Correspondent
Broadwest Corp.
260 W. Broadway
New York,  NY  10013
Correspondent Contact JACK DONOVAN
Regulation Number890.1615
Classification Product Code
IKE  
Date Received11/20/1986
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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