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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 K102728
Device Name ARSTASIS 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 Received09/22/2010
Decision Date 10/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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