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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K040029
Device Name SAFETYNET GUIDEWIRE INTRODUCER
Applicant
INJECTIMED, INC.
6442 MERLIN DRIVE
carlsbad,  CA  92009
Applicant Contact george c brdlik
Correspondent
INJECTIMED, INC.
6442 MERLIN DRIVE
carlsbad,  CA  92009
Correspondent Contact george c brdlik
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/08/2004
Decision Date 04/05/2004
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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