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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K872981
Device Name ACS INDEFLATOR PLUS (MODIFICATION #2)
Applicant
Advanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Applicant Contact KEVIN CORRIGAN
Correspondent
Advanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Correspondent Contact KEVIN CORRIGAN
Regulation Number870.1650
Classification Product Code
DXT  
Date Received07/31/1987
Decision Date 10/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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