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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, long-term greater than 30 days
510(k) Number K092306
Device Name SECURACATH UNIVERSAL
Applicant
INTERRAD MEDICAL, INC.
555 13TH STREET NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
INTERRAD MEDICAL, INC.
555 13TH STREET NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received07/29/2009
Decision Date 07/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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