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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K050561
Device Name WINDSURFER
Applicant
MEDCON LTD.
POB 6718
EFRAT,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
MEDCON LTD.
POB 6718
EFRAT,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/03/2005
Decision Date 05/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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