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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 K854310
Device Name ACS INDEFLATOR (MODIFICATION)
Applicant
Advanced Cardiovascular Systems, Inc.
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact MARIANNA BRESCHINI
Correspondent
Advanced Cardiovascular Systems, Inc.
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact MARIANNA BRESCHINI
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/24/1985
Decision Date 12/04/1985
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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