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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, limb, compressible
510(k) Number K042217
Device Name FLOWMEDIC, MODEL 220
Applicant
FLOWMEDIC (ISRAEL) LTD
555 13TH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN KAHAN
Correspondent
FLOWMEDIC (ISRAEL) LTD
555 13TH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN KAHAN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/16/2004
Decision Date 01/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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