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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 K091367
Device Name GDS-DCS
Original Applicant
2355 calle de luna
santa clara,  CA  95054
Original Contact bonnie mcinerney
Regulation Number870.1340
Classification Product Code
Date Received05/08/2009
Decision Date 11/05/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No