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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K924529
Device Name SIGNATURE(TM) CUSTOM TUBING PACK
Applicant
Avecor Cardiovascular, Inc.
13010 Country Rd. 6
Plymouth,  MN  55441
Applicant Contact DENNIS E STEGER
Correspondent
Avecor Cardiovascular, Inc.
13010 Country Rd. 6
Plymouth,  MN  55441
Correspondent Contact DENNIS E STEGER
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/08/1992
Decision Date 06/23/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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