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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implanted subcutaneous securement catheter
510(k) Number K120935
Device Name SECURACATH
Original Applicant
INTERRAD MEDICAL INC
8401 73rd ave north
ste 63
minneapolis,  MN  55428
Original Contact sew-wah tay
Regulation Number880.5970
Classification Product Code
OKC  
Subsequent Product Code
KMK  
Date Received03/28/2012
Decision Date 04/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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