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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 K894446
Device Name ANGEION HEMOSTASIS VALVE INTRODUCER
Applicant
ANGEION CORP.
13000 HIGHWAY 55
PLYMOUTH,  MN  55441
Applicant Contact GREGORY G BRUCKER
Correspondent
ANGEION CORP.
13000 HIGHWAY 55
PLYMOUTH,  MN  55441
Correspondent Contact GREGORY G BRUCKER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/17/1989
Decision Date 11/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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