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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 K103143
Device Name ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
Applicant
ARSTASIS, INC.
1021 HOWARD AVE
SUITE C
SAN CARLOS,  CA  94070
Applicant Contact DEBRA COGAN
Correspondent
ARSTASIS, INC.
1021 HOWARD AVE
SUITE C
SAN CARLOS,  CA  94070
Correspondent Contact DEBRA COGAN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/25/2010
Decision Date 02/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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